Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
Afatinib IMpurity A Afatinib IMpurity A
Afatinib IMpurity G Afatinib IMpurity G
Articaine IMpurity F (Articaine Acid PropionaMide HCl) Articaine IMpurity F (Articaine Acid PropionaMide HCl)
Avanafil iMpurity 4 Avanafil iMpurity 4 874482-97-0 C8H11Cl2NO
Clopidogrel IMpurity 4 Clopidogrel IMpurity 4 801319-16-4 C15H14ClNO2S
Dehydro Azelnidipine Dehydro Azelnidipine 918659-10-6 C33H32N4O6
DiazepaM IMpurity F DiazepaM IMpurity F 31269-33-7 C16H13ClN2O
LaMotrigine IMpurity LaMotrigine IMpurity
AlviMopan iMpurity AlviMopan iMpurity
Caspofungin iMpurity Caspofungin iMpurity
Saxagliptin iMpurity Saxagliptin iMpurity 2173146-35-3 C18H24ClN3O2
2-(DiethylaMino)-N-(2,3-diMethylphenyl)acetaMide Hydrochloride 2-(DiethylaMino)-N-(2,3-diMethylphenyl)acetaMide Hydrochloride 857170-72-0 C14H23ClN2O
4-Hydroxy Darunavir 4-Hydroxy Darunavir 313682-97-2 C27H37N3O8S
Deschloroaripiprazole Deschloroaripiprazole 203395-81-7 C23H28ClN3O2
O-[(Guanin-9-yl)Methyl] Acyclovir O-[(Guanin-9-yl)Methyl] Acyclovir 166762-90-9 C14H16N10O4
Irbesartan IMpurity E Irbesartan IMpurity E C25H28N6O
LeflunoMide EP IMpurity G LeflunoMide EP IMpurity G 724429-16-7 C12H12N2O2
Telmisartan impurity C Telmisartan impurity C
Itraconazole iMpurity E Itraconazole iMpurity E
Edoxaban Isomer (RRR) Edoxaban Isomer (RRR) 1255529-24-8 C24H30ClN7O4S
1-NaphthaleneacetaMide, 1,2,3,4-tetrahydro-7-Methoxy- 1-NaphthaleneacetaMide, 1,2,3,4-tetrahydro-7-Methoxy- 92041-01-5 C13H17NO2
1,4,7,10-Tetraazacyclododecane-1,7-diacetic acid 1,4,7,10-Tetraazacyclododecane-1,7-diacetic acid 112193-75-6 C12H24N4O4
7-ethyl-5H-chroMeno[2,3-b]pyridin-5-one 7-ethyl-5H-chroMeno[2,3-b]pyridin-5-one 53944-31-3 C14H11NO2
2-Methyl-10H-thieno[2,3-b][1,5]benzodiazepin-4-aMine 2-Methyl-10H-thieno[2,3-b][1,5]benzodiazepin-4-aMine 612503-08-9 C12H11N3S
IMp. A (EP): 8-Chloro-5,10-dihydro-11H-dibenzo[b,e][1,4]diazepin-11-one IMp. A (EP): 8-Chloro-5,10-dihydro-11H-dibenzo[b,e][1,4]diazepin-11-one
IMp. C (EP): 8-Chloro-11-(piperazin-1-yl)-5H- dibenzo[b,e][1,4]diazepine IMp. C (EP): 8-Chloro-11-(piperazin-1-yl)-5H- dibenzo[b,e][1,4]diazepine
21-Dehydro-16α-hydroxy Prednisolone 21-Dehydro-16α-hydroxy Prednisolone 1188271-73-9 C21H26O6
(6α,11β)-11,20-Dihydroxy-6-Methyl-3-oxopregna-1,4,17(20)-trien-21-al (6α,11β)-11,20-Dihydroxy-6-Methyl-3-oxopregna-1,4,17(20)-trien-21-al 1338549-02-2 C22H28O4
(1R)-2-chloro-1-(3,4-difluorophenyl)-1-ethanol (1R)-2-chloro-1-(3,4-difluorophenyl)-1-ethanol 1212376-05-0 C8H7ClF2O
2-[[(3aR,4S,6R,6aS)-6-[7-Chloro-5-(propylthio)-3H-1,2,3-triazolo[4,5-d]pyrimidin-3-yl]tetrahydro-2,2-dimethyl-4H-cyclopenta-1,3-dioxol-4-yl]oxy]-ethanol 2-[[(3aR,4S,6R,6aS)-6-[7-Chloro-5-(propylthio)-3H-1,2,3-triazolo[4,5-d]pyrimidin-3-yl]tetrahydro-2,2-dimethyl-4H-cyclopenta-1,3-dioxol-4-yl]oxy]-ethanol 376608-75-2 C17H24ClN5O4S
Fluconazole IMpurity F Fluconazole IMpurity F C13H12F2N6O
Erlotinib IMpurity A Erlotinib IMpurity A 1058132-82-3 C22H25N3O4
Apixaban iMpurity 5 Apixaban iMpurity 5
cefaclor iMpurity C cefaclor iMpurity C 143059-69-2 C15H14ClN3O4S
ceftazidiMe iMpurity B ceftazidiMe iMpurity B 1236700-64-3
pidotiMod iMpurity D pidotiMod iMpurity D 162148-15-4 C9H12N2O4S
Irinotecan Hydroxyl Acid Irinotecan Hydroxyl Acid 142677-15-4 C22H22N2O6
CyclopropanaMine, 2-(4-fluorophenyl)-(hydrochloride)(1:1),(1R,2S)- CyclopropanaMine, 2-(4-fluorophenyl)-(hydrochloride)(1:1),(1R,2S)- 1314324-00-9 C9H11ClFN
(1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)aMino)-5-(propylsulfinyl)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol (1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)aMino)-5-(propylsulfinyl)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol 1644461-85-7 C23H28F2N6O5S
AtracuriuM IMpurity C (Mixture of DiastereoMers) AtracuriuM IMpurity C (Mixture of DiastereoMers) 86293-35-8
AtracuriuM IMpurity E (cis-Quaternary Acid) AtracuriuM IMpurity E (cis-Quaternary Acid)
AztreonaM IMpurity B AztreonaM IMpurity B
Ceftriaxone IMpurit E Ceftriaxone IMpurit E
Cetirizine IMpurity-6 Cetirizine IMpurity-6 C21H25ClN2O3
Cinacalcet IMpurity 10 Cinacalcet IMpurity 10 1809324-40-0 C29H28F3NO2S
Dasatinib IMpurity 5 Dasatinib IMpurity 5
Diacerein IMpurity F Diacerein IMpurity F 13928-72-8 C35H36O16
D-Valganciclovir Hydrochloride D-Valganciclovir Hydrochloride 1393911-57-3 C14H23ClN6O5
Entecavir IMpurity E Entecavir IMpurity E
EzetiMibe IMpurity 1 EzetiMibe IMpurity 1 190595-66-5 C24H22FNO3
Flurbiprofen IMpurity B Flurbiprofen IMpurity B 1797883-74-9 C18H17FO4
Paroxetine IMpurity Paroxetine IMpurity
7-[(2-aMinoethyl)aMino] -1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 7-[(2-aMinoethyl)aMino] -1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid C14H16FN3O3
(S)-(1R,3s,5S)-8-Methyl-8-azabicyclo[3.2.1]oct-6-en-3-yl 3-hydroxy-2-phenylpropanoate (S)-(1R,3s,5S)-8-Methyl-8-azabicyclo[3.2.1]oct-6-en-3-yl 3-hydroxy-2-phenylpropanoate 61616-97-5 C17H21NO3
(S,R,S,S)-Orlistat (S,R,S,S)-Orlistat 111466-63-8 C29H53NO5
N-Trityl Candesartan Ethyl Ester N-Trityl Candesartan Ethyl Ester 856414-35-2 C45H38N6O3
3R,4S-4-(4-methoxyphenyl)-1-methylpiperi
dinyl] methanol 3R,4S-4-(4-methoxyphenyl)-1-methylpiperi dinyl] methanol 127017-78-1 C14H21NO2
6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(1R,3S,4R)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]- 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(1R,3S,4R)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]- 188399-46-4 C12H15N5O3
4,4'-(2-HYDROXY-1,3-PROPANDIYLDIOXY)BIS(2-PHENYLACETAMIDE) 4,4'-(2-HYDROXY-1,3-PROPANDIYLDIOXY)BIS(2-PHENYLACETAMIDE) 141650-31-9 C19H22N2O5
Valsartan cyano analog methyl ester Valsartan cyano analog methyl ester 137863-90-2 C25H30N2O3
(8S)-2-BroMo α-Ergocryptine (8S)-2-BroMo α-Ergocryptine 65700-36-9 C32H40BrN5O5
3-[4-(4-Chlorobenzoyl)phenoxy]-2-butanone
(Fenofibrate IMpurity) 3-[4-(4-Chlorobenzoyl)phenoxy]-2-butanone (Fenofibrate IMpurity) 217636-47-0 C17H15ClO3
5-(2-Chlorobenzyl)-thieno[3,2-c]pyridiniuM Chloride 5-(2-Chlorobenzyl)-thieno[3,2-c]pyridiniuM Chloride 53885-64-6 C14H11Cl2NS
ClarithroMycin 9-OxiMe ClarithroMycin 9-OxiMe 103450-87-9 C38H70N2O13
Desloratadine N-Hydroxypiperidine Desloratadine N-Hydroxypiperidine 1193725-73-3 C19H19ClN2O
O-DesMethyl Venlafaxine Cyclic IMpurity O-DesMethyl Venlafaxine Cyclic IMpurity 1346601-55-5 C16H23NO2
rac-cis-2,3-Dichloro Sertraline Hydrochloride rac-cis-2,3-Dichloro Sertraline Hydrochloride 1198084-29-5 C17H18Cl3N
11β-Hydroperoxy Dienogest 11β-Hydroperoxy Dienogest 106111-43-7 C20H25NO4
2'-Nor ThiaMine 2'-Nor ThiaMine 7770-93-6 C11H15ClN4OS
6α-Methyl Hydrocortisone 21-Acetate 6α-Methyl Hydrocortisone 21-Acetate 1625-11-2 C24H34O6
N1-Losartanyl-losartan (Losartan IMpurity) N1-Losartanyl-losartan (Losartan IMpurity) 230971-71-8 C44H44Cl2N12O
N2-Losartanyl-losartan (Losartan IMpurity) N2-Losartanyl-losartan (Losartan IMpurity) 230971-72-9 C44H44Cl2N12O
N-Ethoxycarbonyl 7-ADCA N-Ethoxycarbonyl 7-ADCA 72820-16-7 C11H14N2O5S
4-PyridinecarboxaMide, N-(2,6-diMethylphenyl)- 4-PyridinecarboxaMide, N-(2,6-diMethylphenyl)- 68280-05-7 C14H14N2O
4-N-Desacetyl-5-N-acetyl OseltaMivir 4-N-Desacetyl-5-N-acetyl OseltaMivir 956267-10-0 C16H28N2O4
rac N-DesMethyl-N-(4-Methoxyphenethyl) Venlafaxine rac N-DesMethyl-N-(4-Methoxyphenethyl) Venlafaxine 1346601-14-6 C25H35NO3
11-Keto Oxcarbazepine 11-Keto Oxcarbazepine 537693-29-1 C15H10N2O3
Isopropyl 4-(3-AMinophenyl)-1,4-dihydro-5-(2-Methoxyethoxycarbonyl)-2,6-diMethylpyridine-3-carboxylate Isopropyl 4-(3-AMinophenyl)-1,4-dihydro-5-(2-Methoxyethoxycarbonyl)-2,6-diMethylpyridine-3-carboxylate 155861-24-8 C21H28N2O5
(E)-Olopatadine (E)-Olopatadine 113806-06-7 C21H23NO3
NeMadipine B NeMadipine B 79925-38-5 C19H21Cl2NO4
N-[(3,4-DiMethoxy-2-pyridinyl)Methyl] Pantoprazole N-[(3,4-DiMethoxy-2-pyridinyl)Methyl] Pantoprazole 957470-59-6 C24H24F2N4O6S
4-Epi-6-epi Doxycycline 4-Epi-6-epi Doxycycline 97583-08-9 C22H24N2O8
Sertraline-d3 hydrochloride Sertraline-d3 hydrochloride C17H15Cl3D3N
Ethyl 3,4-O-Isopropylidene-5-O-methanesulfonylshikimate Ethyl 3,4-O-Isopropylidene-5-O-methanesulfonylshikimate 204254-84-2 C13H20O7S
2-PyrazinecarboxaMide, N,N',N''-[2,4,6-boroxintriyltris[[(1R)-3-Methylbutylidene]iMino[(1S)-2-oxo-1-(phenylMethyl)-2,1-ethanediyl]]]tris- 2-PyrazinecarboxaMide, N,N',N''-[2,4,6-boroxintriyltris[[(1R)-3-Methylbutylidene]iMino[(1S)-2-oxo-1-(phenylMethyl)-2,1-ethanediyl]]]tris- 390800-88-1 C57H69B3N12O9
D-hydroxyphenylglycylamoxicillin) D-hydroxyphenylglycylamoxicillin) 188112-75-6 C24H26N4O7S
Salmeterol Related Compound B (10 mg) (4-{1-Hydroxy-2-[6-(4-phenylbutan-2-yloxy)hexylamino]ethyl}-2-(hydroxymethyl)phenol) Salmeterol Related Compound B (10 mg) (4-{1-Hydroxy-2-[6-(4-phenylbutan-2-yloxy)hexylamino]ethyl}-2-(hydroxymethyl)phenol) 108928-81-0 C25H37NO4
N-[3-[3-(1-Piperidinylmethyl)phenoxy]propyl]amine N-[3-[3-(1-Piperidinylmethyl)phenoxy]propyl]amine 73278-98-5 C15H24N2O
7,10-Bis-O-(2,2,2-trichloroethoxycarbonyl)-10-deacetylbaccatin III 7,10-Bis-O-(2,2,2-trichloroethoxycarbonyl)-10-deacetylbaccatin III 95603-44-4 C35H38Cl6O14
4-(3-AMino-phenyl)-Morpholin-3-one 4-(3-AMino-phenyl)-Morpholin-3-one 1082495-22-4 C10H12N2O2
IMatinib DiPiperidine IMpurity IMatinib DiPiperidine IMpurity
levocetirizine IMpurity levocetirizine IMpurity
OseltaMivir IMpurity F OseltaMivir IMpurity F
RocuroniuM BroMide IMpurity 19 RocuroniuM BroMide IMpurity 19
S-(+)-O-DesMethyl-Venlafaxine-d6 S-(+)-O-DesMethyl-Venlafaxine-d6 1062609-99-7 C16H25NO2
SalMeterol IMpurity F SalMeterol IMpurity F C25H37NO4
Sitagliptin Defuoro IMpurity 4 Sitagliptin Defuoro IMpurity 4 486459-98-7 C15H19F2NO4
Sulpiride IMpurity F Sulpiride IMpurity F
trans-Ibuprofen IMpurity G trans-Ibuprofen IMpurity G 1391054-15-1 C26H32O4
EthanediaMide  iMpurity F EthanediaMide iMpurity F 480452-37-7 C16H22ClN5O3
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