GB 2760-96: can be used for all types of food; take GMP as the limitation.
FAO/WHO(1984, g/kg): Cream cheese 5; cooked ham, cooked pig forelegs, according to GMT; cottage cheese 5 (by cream); cream 5 (only used for Pasteurized whipped cream or whipped cream with ultra-high temperature sterilization cream and sterile cream).
During the manufacturing of ice cream, gelatin can be used as a protective colloid to prevent the ice crystal from increasing, making the product taste fine, need to be added of about 0.5%. Yogurt, cheese and other dairy products needs to be added of about 0.25%, being able to prevent precipitation of water and enabling the fine texture.
In the manufacture of gelatin dessert (dessert, the main ingredient is gelatin), candy, candy, protein sugar, chocolate, etc. (add 1% to 3.5%, up to 12%).
It is widely applied of gelatin in the luncheon meat, corned beef and other canned food so that the gravy water can be combined to maintain the product shape, humidity and flavor; add about 1% to 5% the weight of meat.
It can also be used as a thickening of soy sauce.
Industrial gelatin appears as colorless or light yellow transparent or translucent flakes or powder. It is tasteless and odorless. It will absorb water for swelling in cold water. It can be dissolved in hot water, being soluble in glycerol and acetic acid, but insoluble in ethanol and ether.
1. It can be applied to printing and dyeing and other industries
2. As a thickening agent, China provided that it can be used for all types of food with appropriate application according to production needs. It can also be used as the clarification agent of alcohol and hydrophobic colloidal stabilizer.
3. It is a kind of hydrophilic colloid with protective colloid effect. It can be used as a hydrophobic colloid stabilizer, emulsifier. It is also a kind of amphoteric electrolyte and can be condensed into pieces of charged particles, which can be used as the clarifier of wine and alcohol. As a dispersant, binder, thickener, stabilizer and emulsifier, it is widely used in photosensitive materials, pharmaceuticals, food, paper, printing, textile, printing and dyeing, electroplating, cosmetics, bacterial culture and pesticide.
4. It can be used as the protective colloid during turbidity or colorimetric determination; also used for the preparation of photographic plate and medium.
5. It can be used as the food quality improver
6. Thickeners; stabilizers; clarifying agents; blowing agents.
7. Gelatin is a hydrophilic colloid with the nature of protecting colloid. It can be used as a hydrophobic colloid stabilizer, emulsifier. But also as the amphoteric electrolyte, it can be enable the condensation of the charged particles into pieces in the aqueous solution; it can be used as wine, alcohol clarifier.
8. It can be used as excipient suspensions, and media.
9. According to the functional properties of gelatin, its application can be divided into two categories. Class I: taking its colloidal protective capacity as a dispersant for the production of PVC, photographic materials, bacterial culture and pharmaceutical, food (such as candy, ice cream, cod liver oil capsules, etc.). Class II: application of its adhesive capacity as adhesive for being applied to paper, printing, textile, printing and electroplating and other industrial sectors. According to different applications, the quality requirements of gelatin is not the same. Gelatin, when being used as adhesive agent in adhesive tape, paper containers, paper tubes and binding, etc. has the bonding strength be the main value factor; when applied to the fields of photography, food and medicine, people emphasize more on the product purity. The national standard number of edible gelatin in China is GB6783-86; the usage range and maximum allowable amount should be referred to GB2760-86.
There are mainly lime cream method, hydrochloric acid method and enzymatic method. 1. Lime cream method; cut off the inner layer grease of the degenerated foot skin of cowhide and pigskin and cut into small pieces, place in the 3.5%-4.0% lime cream for soaking of about 30-40d during which the lime cream is changed for 4-6 times. During the soaking process, stir uniformly. The soaked raw hides are taken out from the lime cream tank and washed clean with water; neutralized with 10% hydrochloric acid for 3-4 h under stirring, and the pH should be 6.0-6.5 after washing. And then the pork skin was added into water at a 1: 1 ratio and heated and cooked with the temperature being controlled at 60-70 ℃. Extract the glue water at regular intervals and filter with clean gauze while hot; repeat the above process for a total of 5-6 times. The thin glue water is further sent into the evaporator for concentration to make a relative density of 1.03-1.07. The hot glue is further transferred into the aluminum plate for cooling. The cold plastic is put into the stainless screen and further sent into the drying room for blast drying with the temperature strictly controlled at around 28 ℃.
The dried film is crushed to obtain the finished product. The yield was about 22% by weight of the pig skin. 2. Hydrochloric acid method: the miscellaneous bone, spine and small bone are crushed; use benzene to extract the oil in the 45-50 ° C before washing with water. The washed bone is soaked with 3.5-4.0% hydrochloric acid. After the main bone becomes soft, we can obtain the crude ossein, wash with water so that the pH of the aqueous solution is around 3.5. Addition of lime cream can enable the manufacturing of calcium hydrogen phosphate and dry calcium chloride. The bones is further subject to soaking with over 3.0%-3.5% lime cream for 30-50d (during this time, change the lime cream for 5-6 times). Take it out and wash with water for about 1h. The clean ossein at this time is subject to neutralization with 0.2 hydrochloric acid hydrochloride for the first time. When the pH is dropped to 3.5-4.0, let the neutralization solution go. Add clean water and then neutralize with 0.5% hydrochloric acid for about 2h. When the acid concentration decreased to 0.2-0.25%, the acid concentration is immediately increased to 1% and the concentration was maintained until the neutralization end point (pH 3.0) was reached.
After the completion of the neutralization, the ossein is fully washed with water and soaked for 4-5h. Then wash with sodium hydroxide solution and add dilute alkaline solution for soaking of 16-20h before rinsing with water. At this stage, we can obtain refined ossein. After 7 days of degelatinization of the refined ossein, the glue is obtained. The water amount and temperature of each channel should be controlled separately with the water amount being reduced along with the channel and the gel temperature increased by the road, from 64 ℃ at the first channel to 85 ℃ at the 7th channel. The concentration of the glue from the first to the seventh also decreases from 8% to 2-3%. The whole process of degelatinization lasts for about 40h. The obtained thin glue water is filtered and concentrated to a density of 1.025-1.075. It is then frozen on the plastic box, sliced and placed on the screen, and further sent to the drying room for air drying with the temperature being gradually raised from 25 ℃ to 60 ℃. The finished product is obtained after the dryness. The quality of the gelatin in different channels was different. According to the road, it is divided into camera glue, edible glue, and finally the baking glue for making peptone. The rate of good glue is higher than 60%. Per ton of product consumption: about 7t of bone; about 7 t of 30% hydrochloric acid.
The Chang Yuanming gelatin factory (Ding Chen district in Changde City) applies the chromium leather corner scrap (blue alum skin) during the leather production for production of gelatin. The process is as follows: blue alum skin → broken → liming → leaching → leaching → leaching → Extraction → concentration → dripping → drying → crushing. Consumption of raw material (kg/t): blue alum skin 4000 sulfuric acid (98%) 1000 hydrochloric acid (31%), 200 lime 1000. (3) enzymatic hydrolysis; use protease to hydrolyze the collagen into gelatin; add dilute hydrochloric acid to dissolve it, and then use the acetone, sodium sulfate and sodium chloride to precipitate the gelatin out. This method is not yet mature with the current production shortening the soaking time. The detailed process: the degreasing raw material is washed with NaOH solution (pH = 11~12) for 24 hour; then subject to enzymatic hydrolysis with 2907 alkaline protease at 40 ℃ for 6 h. After water washing, use acid for soaking (PH = 2~2.5) 1 day; wash to a pH of 5.8~6.0, then apply gray soaking for another 3~10 d.
Finishing and degreasing of raw material; have the different varieties of raw materials subject to sorting and selection. The finished skin raw materials is soaked in 1% lime water for dipping of 1-2h, and then cut into pieces and added into the dewatering machine to obtain the degreased broken skin.
Skin [classification; degreasing; maceration] → softened skin [lime water] → debris [hydraulic degreasing] → degreasing broken skin
Dipping, washing; the degreased broken skin is soaked with 2%-4% lime water with the ratio of wet skin and water of 1: 3-1: 4 and pH of 12-12.5. The optimal temperature is 15 ℃ and the time should be around 15-90 days. The impregnated raw material was thoroughly washed with water and stirred continuously. During the initial 5h, change the water every 0.5h once; then change to: 1h interval. The ratio of raw material to water should not be less than 1: 5 with the total time being around 12-16h and the final pH being 9-9.5. Use 6 mol/L hydrochloric acid to neutralize the rest lime so that the pH is around 2.5-3.5. At the range of 1-3 h, adjust the pH value once every 0.5 h; At the rang of 3-8h, adjust the pH value once every 1h; stop adjusting the pH value after 8h; The whole neutralization process should take 12-16h. After the neutralization, remove the acid and wash with water for not less than 8 times and complete the process with 8-12h.
Degreased broken skin [Lime water,> 15 days] → [pH12, 15 ℃] debris after dipping [water, HCl] → [pH2.5-3.5] → glue raw material.
Finishing and concentration; first add heating water into the degelatinize pot, further supply raw materials and avoid forming lumps. Slowly heat to a temperature of 50-60 ℃ so that the water can immerse the raw materials thoroughly. After 3-8 h, give off the glue and then add hot water with the temperature being adjusted to 65-75 ℃ and continue the process. Repeat the above process for several times with the temperature being gradually increased and finally up to boiling. Take the dilute glue solution of about 60 ℃, add activated carbon or diatomaceous earth as filter aid, apply plate-and-frame filter press for filtering to obtain the clarified glue solution, and then centrifuge to degrease, apply vacuum concentration at a temperature of 65 ℃. And finally concentrated to a specific gravity of 1.05-1.08 (50 ℃), containing 23%-33% glue.
Preparation of glue raw material [hot water] → [50-60 ℃; after boiling] dilute gelatin liquid [concentration] → [60-65 ℃] concentrated gelatin.
Gelatinization and drying; the concentrated gelatin solution is added while hot of hydrogen peroxide or sulfurous acid for anti-corrosion or bleaching, and then poured into the metal plate or the model to be cooled to generate jelly so far. The jelly is cut into appropriate pieces or pieces and dried with cold and hot air to its water content of 10%-12% and crushed to obtain the finished product.
Concentrated gelatin solution [gel] → jelly [cut rubber, dry] → finished product.
ADI doesn’t make restrictive regulations (FAO/WHO, 2001).
Description
Gelatin does not occur in nature as such, but is derived by hydrolysis
of collagen, the chief protein component in connective tissues
of the animal body. Extraction of gelatin for use as a glue by
cooking hides dates back to the earliest recorded history of man
and appears in the literature of the items up to the present day.
During the early years of the Napoleonic era it was manufactured
on a large scale in an attempt to alleviate the food shortages
resulting from the English naval blockade of Europe. Gelatin was
first manufactured in the U.S. in 1809. In 1845 a U.S. patent was
granted for a gelatin which contained all the ingredients fitting it
for table use, and required only the addition of hot water and
subsequent cooling to prepare it for serving. Quantitatively, collagen is concentrated in the skin, the bone of
the skeletal system and the tendons attaching muscles to the skeleton,
although it occurs throughout all of the tissues and organs
to a lesser degree. Chemically, collagen and gelatin are virtually
indistinguishable, but the process of collagen extraction results in
converting the fibrous, water-insoluble, highly organized macromolecules
(tropocollagens) irreversibly into gelatin which has dissimilar
physical characteristics. Variations in gelatin properties due
to source and treatment make it a highly diverse, heterogeneous
substance, particularly with regard to molecular weight. The major sources of collagen are cattle hides, pig skins and bones.
The resulting gelatin is of two types commonly designated A and
B, depending upon which of two processes are used to convert the
collagen into gelatin. Type A gelatin is derived primarily from pig
skin by acid processing; it has an isoelectric point between pH 7
and pH 9. Type B is from cattle hides and bones by alkaline or lime processing and has an isoelectric point between pH 4.7 and
pH 5.1. Gelatin from different sources and as prepared by the
different processes exhibits small differences in amino acid composition
as shown in the following table. The nutritionally essential
amino acid, tryptophan, is absent in gelatin. Gelatin also is unusual
in that it contains large proportions of glycine, proline and hydroxyproline,
and a small percentage of hydroxylysine, an amino acid
rare in proteins. (SCOGS, 1975). The major use of gelatin in the U.S. is in food products, principally
in gelatin desserts, meat products, consommes, marshmallows,
candies, bakery and dairy products and ice cream. A substantial
portion of each year’s production (imported and domestic) is also
used in the pharmaceutical, photographic and paper industries.
(SCOGS, 1975). Gelatin is colorless or slightly yellow, transparent, brittle, practically
odorless, tasteless, presenting as sheets, flakes or a coarse
powder. On being warmed, gelatin disperses into the water resulting
in a stable suspension. Water solutions of gelatin will form a
reversible gel if cooled below the specific gel point of gelatin. The
gel point is dependent on the source of the raw material. Gelatin
extracted from the tissues of warm-blooded animals will have a
gel point in the range of 30°C - 35°C. Gelatin extracted from the skin of cold-water ocean fish will have a gel point in the range of
5°C - 10°C. Gelatin is soluble in aqueous solutions of polyhydric
alcohols such as glycerin and propylene glycol.
Chemical Properties
white to slightly yellow powder, also knownas glutin,is a protein found in many animal tissues including skin, cartilage, horn, and bone. Gelatin is used in leather dressings, in photography, in metallurgy, in the plastics industry, and in pharmaceuticals.
Chemical Properties
Gelatin occurs as a light-amber to faintly yellow-colored, vitreous,
brittle solid. It is practically odorless and tasteless, and is available
as translucent sheets, flakes, and granules, or as a coarse powder.
Occurrence
Gelatin is a protein obtained by partial hydrolysis of collagen, the chief protein component in skin, bones, hides, and white connective tissues of the animal body. Type A gelatin is produced by acid processing of collagenous raw material; type B is produced by alkaline or lime processing. Because it is obtained from collagen by a controlled partial hydrolysis and does not exist in nature, gelatin is classified as a derived protein. Animal glue and gelatin hydrolysate, sometimes referred to as liquid protein, are products obtained by a more complete hydrolysis of collagen and can thus be considered as containing lower molecular-weight fractions of gelatin.
Uses
Gelatin is a protein that functions as a gelling agent. it is obtained
from collagen derived from beef bones and calf skin (type b) or pork
skin (type a). type b is derived from alkali-treated tissue and has an
isoelectric point between ph 4.7 and 5.0. type a is derived from
acid-treated tissue and has an isoelectric point between ph 7.0 and
9.0. it forms thermally reversible gels which set at 20°c and melt at
30°c. the gel strength is measured by means of a bloom gellometer
and ranges from 50 to 300 with a 250 bloom being the most common.
it is used in desserts at 8–10% of the dry weight, in yogurt at 0.3–0.5%,
in ham coatings at 2–3%, and in confectionery and capsules at
1.5–2.5%.
Uses
As stabilizer, thickener and texturizer in food; manufacture of rubber substitutes, adhesives, cements, lithographic and printing inks, plastic Compounds, artificial silk, photographic plates and films, matches, light filters for mercury lamps; clarifying agent; in hectographic masters; sizing paper and textiles; for inhibiting crystallization in bacteriology, for preparing cultures. Pharmaceutic aid (suspending agent; encapsulating agent; tablet binder; tablet and coating agent). Gelatin is a hydrophilic chemical useful in histochemistry, bacterial culture media and light microscope autoradiography.
Uses
gelatin is used as a natural sealant against moisture loss and as a formulation thickener. The films produced by gelatin are tacky when moist and hard, and brittle when dry. It is obtained by the partial hydrolysis of mature collagen derived from the skin, connective tissue, and bones of animals. It does not have the waterbinding ability of soluble collagen.
Definition
Amixture of proteins obtained by hydrolysis
of collagen by boiling skin, ligaments, tendons,
etc. Its production differs from that of animal
glue in that the raw materials are selected,
cleaned, and treated with special care so that the
product is cleaner
Production Methods
Gelatin is extracted from animal tissues rich in collagen such as skin,
sinews, and bone. Although it is possible to extract gelatin from
these materials using boiling water, it is more practical to first
pretreat the animal tissues with either acid or alkali. Gelatin
obtained from the acid process is called type A, whereas gelatin
obtained from the alkali process is called type B.
The acid-conditioning process (manufacture of type A gelatin) is
restricted to soft bone ossein (demineralized bones), sinew, pigskin,
calfskin and fish skins for reasons of gaining sufficient yield. The
material is cut in pieces and washed in cold water for a few hours to
remove superficial fat. It is then treated with mineral acid solutions,
mainly HCl or H2SO4, at pH 1–3 and 15–20°C until maximum
swelling has occurred. This process takes approximately 24 hours.
The swollen stock is then washed with water to remove excess acid,
and the pH is adjusted to pH 3.5–4.0 (pigskin, fish skin) or 2.0–3.5
(all other tissues) for the conversion to gelatin by hot-water
extraction.
The hydrolytic extraction is carried out in a batch-type operation
using successive portions of hot water at progressively higher
temperatures (50–75°C) until the maximum yield of gelatin is
obtained. The gelatin solution is then filtered through previously
sterilized cellulose pads, deionized, concentrated to about 20–25%
w/v and sterilized by flashing it to 138°C for 4 seconds. The dry
gelatin is then formed by chilling the solution to form a gel, which is
air-dried in temperature-controlled ovens. The dried gelatin is
ground to the desired particle size.
In the alkali process (liming), demineralized bones (ossein) or
cattle skins are usually used. The animal tissue is held in a calcium
hydroxide (2–5% lime) slurry for a period of 2–4 months at
14–18°C. At the end of the liming, the stock is washed with cold
water for about 24 hours to remove as much of the lime as possible.
The stock solution is then neutralized with acid (HCl, H2SO4,
H3PO4) and the gelatin is extracted with water in an identical
manner to that in the acid process, except that the pH is kept at
values between 5.0–6.5 (neutral extraction).
During the preparation of the bovine bones used in the
production of gelatin, specified risk materials that could contain
transmissible spongiform encephalopathies (TSEs) vectors are
removed. TSE infectivity is not present in pharmaceutical grade
gelatin.
Definition
A pale yellow
protein obtained from the bones, hides,
and skins of animals, which forms a colloidal
jelly when dissolved in hot water. It
is used in jellies and other foods, to make
capsules for various medicinal drugs, as an
adhesive and sizing medium, and in photographic
emulsions.
General Description
Gelatin, NF, is a protein obtained by the partial hydrolysis of collagen, an albuminoid found in bones, skin, tendons, cartilage, hoofs, and other animal tissues. Gelatin is used in the preparation of capsules, in the coating of tablets, and, with glycerin, as a vehicle for suppositories. It has also been used as a vehicle when slow absorption is desired for drugs.
Agricultural Uses
Gelatin is a colorless or pale yellow water-soluble protein obtained by boiling collagen with water and evaporating the water. It is an ingredient in jellies and baked goods. It is also used to make medicinal capsules, and coat photographic films.
Pharmaceutical Applications
Gelatin is widely used in a variety of pharmaceutical formulations,
including its use as a biodegradable matrix material in an
implantable delivery system, although it is most frequently used
to form either hard or soft gelatin capsules.
Gelatin capsules are unit-dosage forms designed mainly for oral
administration. Soft capsules on the market also include those for
rectal and vaginal administration. Hard capsules can be filled with
solid (powders, granules, pellets, tablets, and mixtures thereof),
semisolid and liquid fillings, whereas soft capsules are mainly filled
with semisolid or liquid fillings. In hard capsules, the active drug is
always incorporated into the filling, while in soft capsules the drug
substance can also be incorporated into the thick soft capsule shell.
Gelatin is soluble in warm water (>30°C), and a gelatin capsule will
initially swell and finally dissolve in gastric fluid to release its
contents rapidly.
Hard capsules are manufactured in two pieces by dipping
lubricated stainless steel mold pins into a 45–55°C gelatin solution
of defined viscosity, which depends on the size of the capsules and
whether cap or body are to be formed. The gelatin is taken up by the
pins as a result of gelation, and the resulting film thickness is
governed by the viscosity of the solution. The capsule shells are
passed through a stream of cool air to aid setting of the gelatin, and
afterwards they are slowly dried with large volumes of humidity
controlled air heated to a few degrees above ambient temperature
and blown directly over the pins. The capsule halves are removed
from their pins, trimmed and fitted together. Gelatin that is used to
produce hard capsules may contain various coloring agents and
antimicrobial preservatives. Surfactants may be present in small
quantities in the shells being a residue of the pin lubricant. However,
the use of preservatives is no longer encouraged in line with current
GMP principles. Capsule shells may be treated with formaldehyde
to make them insoluble in gastric fluid. Standard capsules vary in
volume from 0.13 to 1.37 mL. For veterinary use, capsules with a
volume between 3 and 28mL are available, and capsules with a
capacity of 0.025mL are available for toxicity studies in rats.
In contrast to two-piece hard capsules, soft gelatin capsules are
manufactured, filled and sealed in one process. The gelatin used to
form the soft shells has a lower gel strength than that used for hard
capsules, and the viscosity of the solutions is also lower, which
results in more flexible shells. Additives to soft shell formulations
are plasticizers such as polyalcohols (glycerin, propylene glycol,
polyethylene glycol). Sorbitol can be added as moisturizing agent,
whereby the larger amount of water will act as plasticizer. Coloring
and opacifying agents are also added. The filling can interact with
the gelatin and the plasticizer chemically. There may be migration of
filling components into the shell and plasticizer from the shell into
the filler. These interactions have to be taken into account during the
formulation of the gelatin shell and the filling. The main method to
produce soft gelatin capsules is the rotary die method (RP Scherer),
and an alternative method for small volumes of round capsules is
the Globex system (Industrial Techno-logic Solutions Ltd). Soflet
Gelcaps (Banner Pharmacaps) are tablets that have been coated
with a gelatin film.
Gelatin is also used for the microencapsulation of drugs, where
the active drug is sealed inside a microsized capsule or beadlet,
which may then be handled as a powder. The first microencapsulated
drugs (beadlets) were fish oils and oily vitamins in gelatin
beadlets prepared by coacervation.
Low-molecular-weight gelatin has been investigated for its
ability to enhance the dissolution of orally ingested drugs.
Ibuprofen–gelatin micropellets have been prepared for the controlled
release of the drug. Other uses of gelatin include the
preparation of pastes, pastilles, pessaries, and suppositories. In
addition, it is used as a tablet binder and coating agent, and as a
viscosity-increasing agent for solutions and semisolids.
Therapeutically, gelatin has been used in the preparation of
wound dressings and has been used as a plasma substitute,
although anaphylactoid reactions have been reported in the latter
application. Absorbable gelatin is available as sterile film,
ophthalmic film, sterile sponge, sterile compressed sponge, and
sterile powder from sponge. Gelatin sponge has hemostatic
properties.
Gelatin is also widely used in food products and photographic
emulsions.
8
Biochem/physiol Actions
Gelatin from fish skin can be used in the preparation of various gels based on their gelling characteristics. It can also be used as an additive in surimi processing to enhance the functional and mechanical properties of gel.
Safety Profile
An experimental teratogen. Experimental reproductive effects. When heated to decomposition it emits acrid smoke and irritating fumes.
Safety
Gelatin is widely used in a variety of pharmaceutical formulations,
including oral and parenteral products.
In general, when used in oral formulations gelatin may be
regarded as a nontoxic and nonirritant material. However, there
have been rare reports of gelatin capsules adhering to the
esophageal lining, which may cause local irritation. Hypersensitivity
reactions, including serious anaphylactoid reactions, have
been reported following the use of gelatin in parenteral products.
There have been concerns over the potential spread of BSE/TSE
infections through bovine derived products. However, the risk of
such contamination of medicines is extremely low.
LD50 (rat, oral): 5 g/kg
TDLo (mouse, IP): 700 mg/kg
storage
Dry gelatin is stable in air. Aqueous gelatin solutions are also stable
for long periods if stored under cool conditions but they are subject
to bacterial degradation. At temperatures above about 50°C,
aqueous gelatin solutions may undergo slow depolymerization and
a reduction in gel strength may occur on resetting. Depolymerization
becomes more rapid at temperatures above 65°C, and gel
strength may be reduced by half when a solution is heated at 80°C
for 1 hour. The rate and extent of depolymerization depends on the
molecular weight of the gelatin, with a lower-molecular-weight
material decomposing more rapidly.Dry gelatin is stable in air. Aqueous gelatin solutions are also stable
for long periods if stored under cool conditions but they are subject
to bacterial degradation.(4) At temperatures above about 50°C,
aqueous gelatin solutions may undergo slow depolymerization and
a reduction in gel strength may occur on resetting. Depolymerization
becomes more rapid at temperatures above 65°C, and gel
strength may be reduced by half when a solution is heated at 80°C
for 1 hour. The rate and extent of depolymerization depends on the
molecular weight of the gelatin, with a lower-molecular-weight
material decomposing more rapidly.
Gelatin may be sterilized by dry heat.
The bulk material should be stored in an airtight container in a
cool, well-ventilated and dry place.
Incompatibilities
Gelatin is an amphoteric material and will react with both acids and
bases. It is also a protein and thus exhibits chemical properties
characteristic of such materials; for example, gelatin may be
hydrolyzed by most proteolytic systems to yield its amino acid
components.
Gelatin will also react with aldehydes and aldehydic sugars,
anionic and cationic polymers, electrolytes, metal ions, plasticizers,
preservatives, strong oxidizers, and surfactants. It is precipitated by
alcohols, chloroform, ether, mercury salts, and tannic acid. Gels can
be liquefied by bacteria unless preserved.
Some of these interactions are exploited to favorably alter the
physical properties of gelatin: for example, gelatin is mixed with a
plasticizer, such as glycerin, to produce soft gelatin capsules and
suppositories; gelatin is treated with formaldehyde to produce
gastroresistance.
Regulatory Status
GRAS listed. Included in the FDA Inactive Ingredients Database
(dental preparations; inhalations; injections; oral capsules, pastilles,
solutions, syrups and tablets; topical and vaginal preparations).
Included in medicines licensed in the UK, Europe, and Japan.
Included in the Canadian List of Acceptable Non-medicinal
Ingredients.
