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
AztreonaM IMpurity F AztreonaM IMpurity F 102579-57-7 C15H21N5O8S2
BendaMustine Dideschloroethyl IMpurity BendaMustine Dideschloroethyl IMpurity
BroMocriptine IMpurity F BroMocriptine IMpurity F 82773-21-5 C32H40BrN5O5
Cephalexin IMpurity J Cephalexin IMpurity J C16H17N3O4S
Cetirizine IMpurity (4-Chlorobenzophenone) Cetirizine IMpurity (4-Chlorobenzophenone) 2724877-99-8 C21H25ClN2O3
Dasatinib IMpurity 3 Dasatinib IMpurity 3
Deferasirox IMpurity 2 Deferasirox IMpurity 2
Desvenlafaxine (O-DesMethyl Venlafaxine) FuMarate Desvenlafaxine (O-DesMethyl Venlafaxine) FuMarate 93414-04-1 C20H29NO6
EzetiMibe Dehydoxy IMpurity EzetiMibe Dehydoxy IMpurity 204589-58-2 C24H21F2NO2
Flurbiprofen IMpurity E Flurbiprofen IMpurity E
Levocarnitine IMpurity D Levocarnitine IMpurity D
Montelukast EP IMpurity E Montelukast EP IMpurity E 1187586-58-8 C41H46ClNO5S2
Prasugrel IMpurity 6 Prasugrel IMpurity 6
RebaMipide 2-Chloro IMpurity RebaMipide 2-Chloro IMpurity 90098-06-9 C19H15ClN2O4
Ribavirin IMp. F (EP) Ribavirin IMp. F (EP)
RocuroniuM BroMide IMpurity 17 RocuroniuM BroMide IMpurity 17
SalMeterol IMpurity D SalMeterol IMpurity D C25H37NO4
SulbactaM IMpurity A SulbactaM IMpurity A
IMp. C (EP) IMp. C (EP)
Methyl 3-aMino-2-((2'-carbaMoylbiphenyl-4-yl)MethylaMino)benzoate Methyl 3-aMino-2-((2'-carbaMoylbiphenyl-4-yl)MethylaMino)benzoate 147404-75-9 C22H21N3O3
3-Methyl cefdinir 3-Methyl cefdinir 71091-93-5 C13H13N5O5S2
3-Methyl- N-[4-trifluo- roMethyl) phenyl]-4- isoxazole carboxaMide 3-Methyl- N-[4-trifluo- roMethyl) phenyl]-4- isoxazole carboxaMide
2-[[[4-(2,2,2-Trifluoroethoxy)-3-Methyl-1-oxopyridin-2-yl]Methyl]sulfanyl]-1H-benziMidazole 2-[[[4-(2,2,2-Trifluoroethoxy)-3-Methyl-1-oxopyridin-2-yl]Methyl]sulfanyl]-1H-benziMidazole 163119-30-0 C16H14F3N3O2S
(11β,16β)-9-BroMo-11-hydroxy-16-Methyl-17,21-bis(1-oxopropoxy)pregna-1,4-diene-3,20-dione (11β,16β)-9-BroMo-11-hydroxy-16-Methyl-17,21-bis(1-oxopropoxy)pregna-1,4-diene-3,20-dione 52092-14-5 C28H37BrO7
ClotriMazole IMpurity A ClotriMazole IMpurity A 23593-71-7 C22H17ClN2
9-Nitrominocycline 9-Nitrominocycline 149934-16-7 C23H26N4O9
N-(3,5-DiMethyladaMantan-1-yl)forMaMide N-(3,5-DiMethyladaMantan-1-yl)forMaMide 351329-88-9 C13H21NO
N-(Methylsulfonyl)-4'-nitro-2'-phenoxyMethanesulfonanilide N-(Methylsulfonyl)-4'-nitro-2'-phenoxyMethanesulfonanilide 51765-72-1 C14H14N2O7S2
Olanzapine ThioacetoxyMethylidene IMpurity

Discontinued Olanzapine ThioacetoxyMethylidene IMpurity Discontinued 1320360-87-9 C17H20N4O2S
1-NaphthaleneethanaMine, 7-Methoxy-N-[2-(7-Methoxy-1-naphthalenyl)ethyl]- 1-NaphthaleneethanaMine, 7-Methoxy-N-[2-(7-Methoxy-1-naphthalenyl)ethyl]- 1385018-57-4 C26H27NO2
24R-Calcipotriol 24R-Calcipotriol 112827-99-3 C27H40O3
Methotrexate IMpurity C Methotrexate IMpurity C
Paroxetine EP IMpurity G Paroxetine EP IMpurity G 69675-10-1 C12H14FN
Itraconazole impurity C Itraconazole impurity C
1-cyclopropyl-8-ethoxy-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 1-cyclopropyl-8-ethoxy-6,7-difluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid 143158-55-8 C15H13F2NO4
Tigecycline Metabolite M6 (9-AniMoMinocycline) Tigecycline Metabolite M6 (9-AniMoMinocycline) 149934-19-0 C23H28N4O7
VerapaMil IMpurity G VerapaMil IMpurity G C27H38N2O4
EthanediaMide  iMpurity D EthanediaMide iMpurity D 480452-36-6 C21H30ClN5O5
N-(4-(2-Methyl-5,6-dihydro-4H-benzo[b]oxazolo[5,4-d]azepine-6-carbonyl)phenyl)-[1,1'-biphenyl]-2-carboxaMide N-(4-(2-Methyl-5,6-dihydro-4H-benzo[b]oxazolo[5,4-d]azepine-6-carbonyl)phenyl)-[1,1'-biphenyl]-2-carboxaMide 168626-93-5 C32H25N3O3
1-(4-chlorophenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide 1-(4-chlorophenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide C24H22ClN5O3
Methyl (4-Methylpiperidin-3-yl)carbaMate Methyl (4-Methylpiperidin-3-yl)carbaMate 1204176-45-3 C8H16N2O2
(R)-3-(4-(5-broMo-2-chlorobenzyl)phenoxy)tetrahydrofuran (R)-3-(4-(5-broMo-2-chlorobenzyl)phenoxy)tetrahydrofuran 915095-90-8 C17H16BrClO2
(2S,3R,4S,5S,6R)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)-tetrahydro-6-(hydroxyMethyl)-2-Methoxy-2H-pyran-3,4,5-triol (2S,3R,4S,5S,6R)-2-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)-tetrahydro-6-(hydroxyMethyl)-2-Methoxy-2H-pyran-3,4,5-triol 1358581-37-9 C25H27FO6S
Levocarnitine iMpurity Levocarnitine iMpurity 6490-20-6 C7H17ClN2O2
3-Hydroxy-4-Methyl-2(5H)-thiophenone 3-Hydroxy-4-Methyl-2(5H)-thiophenone 34876-35-2 C5H6O2S
(1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-Hexahydro-3,7-diMethyl-8-[2-[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl Ester (2Z)-2-Methyl-2-butenoic Acid (1S,3R,7S,8S,8aR)-1,2,3,7,8,8a-Hexahydro-3,7-diMethyl-8-[2-[(2R,4R)-tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl]ethyl]-1-naphthalenyl Ester (2Z)-2-Methyl-2-butenoic Acid 1048973-04-1 C24H34O5
(6α)-17,21-Dihydroxy-6-Methylpregna-1,4,9(11)-triene-3,20-dione (6α)-17,21-Dihydroxy-6-Methylpregna-1,4,9(11)-triene-3,20-dione 93269-35-3 C22H28O4
[N(Z)]-N-(3,5-DiMethyl-2(3H)-thiazolylidene)-4-hydroxy-2-Methyl-2H-1,2-benzothiazine-3-carboxaMide 1,1-Dioxide [N(Z)]-N-(3,5-DiMethyl-2(3H)-thiazolylidene)-4-hydroxy-2-Methyl-2H-1,2-benzothiazine-3-carboxaMide 1,1-Dioxide 1262333-25-4 C15H15N3O4S2
Quetiapine Impurity E Quetiapine Impurity E 1371638-05-9 C40H44N6O2S2
Bendamustine Deschloro Dimer Impurity Bendamustine Deschloro Dimer Impurity 1391052-61-1 C32H44N6O7
Benzenepropanoic acid, β-aMino-α-hydroxy-, Methyl ester, (αR,βR)- Benzenepropanoic acid, β-aMino-α-hydroxy-, Methyl ester, (αR,βR)- 157722-44-6 C10H13NO3
Benzenebutanoicacid,b-aMino-2,4,5-trifluoro-,Methylester,(bR)- Benzenebutanoicacid,b-aMino-2,4,5-trifluoro-,Methylester,(bR)- 881995-69-3 C11H12F3NO2
Avanafil iMpurity 2 Avanafil iMpurity 2
Bisoprolol IMpurity Bisoprolol IMpurity 2226263-67-6 C18H31NO4
Brivaracetam Impurity 66 Brivaracetam Impurity 66
2-Acetoxymethyl1-3-Methyl-4- 2-Acetoxymethyl1-3-Methyl-4- 112525-75-4 C11H12F3NO3
N-(7-chloro-4-((3-chloro-4-fluorophenyl)amino)quinazolin-6-yl)-4-(dimethylamino)butanamide N-(7-chloro-4-((3-chloro-4-fluorophenyl)amino)quinazolin-6-yl)-4-(dimethylamino)butanamide
Ertapenem Impurity D(USP) Ertapenem Impurity D(USP)
3-(N-Benzyl-N-methylamino)propiophenone hydrochloride 3-(N-Benzyl-N-methylamino)propiophenone hydrochloride 5409-62-1 C17H20ClNO
2(1H)-Isoquinolinecarboxylic acid, 3,4-dihydro-4-hydroxy-1-phenyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester, (1S,4S)- 2(1H)-Isoquinolinecarboxylic acid, 3,4-dihydro-4-hydroxy-1-phenyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester, (1S,4S)- 869884-24-2 C23H26N2O3
Azilsartan Medoxomil Potassium impurity209 Azilsartan Medoxomil Potassium impurity209
Nelarabine impurity 01 Nelarabine impurity 01
Pyridine, 2-(diethylboryl)- (9CI) Pyridine, 2-(diethylboryl)- (9CI) 385804-67-1 C9H14BN
	Olodaterol Impurity 32 Olodaterol Impurity 32
(R)-Lercanidipine Hydrochloride (R)-Lercanidipine Hydrochloride 187731-34-6 C36H42ClN3O6
2-Oxo Clopidogrel Hydrochloride(Mixture of diastereomers) 2-Oxo Clopidogrel Hydrochloride (Mixture of diastereomers) 109904-27-0 C16H16ClNO3S
5-Hydroxy-6-methoxy-1-indanone 5-Hydroxy-6-methoxy-1-indanone 127399-78-4 C10H10O3
Desfluoro Citalopram Oxalate Desfluoro Citalopram Oxalate 1093072-86-6 C22H24N2O5
Didesmethyl Zolmitriptan Didesmethyl Zolmitriptan 139264-15-6 C14H17N3O2
Gabapentin Related Compound E Gabapentin Related Compound E 67950-95-2 C9H14O4
Hydroxy Bosentan Hydroxy Bosentan 253688-60-7 C27H29N5O7S
Lisinopril S,S,S-Diketopiperazine Lisinopril S,S,S-Diketopiperazine 328385-86-0 C21H29N3O4
rac 4-Desmethoxy-4-nitro Omeprazole rac 4-Desmethoxy-4-nitro Omeprazole 317807-10-6 C16H16N4O4S
trans 1-Benzyl-4-(4-fluorophenyl)-3-piperidinemethanol trans 1-Benzyl-4-(4-fluorophenyl)-3-piperidinemethanol 201855-60-9 C19H22FNO
ETHYL 7-CHLORO-1-ETHYL-6-FLUORO-1,4-DIHYDRO-4-OXO-QUINOLINE-5-CARBOXYLATE ETHYL 7-CHLORO-1-ETHYL-6-FLUORO-1,4-DIHYDRO-4-OXO-QUINOLINE-5-CARBOXYLATE 70458-94-5 C14H13ClFNO3
SRI 62320 SRI 62320 94061-80-0 C24H25FNNaO4
1,3,5,7-Tetrmethyl-adamantane 1,3,5,7-Tetrmethyl-adamantane 1687-36-1 C14H24
4-[1-(hydroxyamino)ethylidene]cyclohexa-2,5-dien-1-one 4-[1-(hydroxyamino)ethylidene]cyclohexa-2,5-dien-1-one 34523-34-7 C8H9NO2
Methyl 4-(4'-fluorophenyl)-2-(cyclopropyl)-3-quinolinecarboxylate Methyl 4-(4'-fluorophenyl)-2-(cyclopropyl)-3-quinolinecarboxylate 121659-86-7 C20H16FNO2
Silodosin Silodosin 160970-64-9 C25H32F3N3O4
(3S)-6,6-DIBROMO-2,2-DIMETHYLPENAM-3-CARBOXYLIC ACID 1,1-DIOXIDE (3S)-6,6-DIBROMO-2,2-DIMETHYLPENAM-3-CARBOXYLIC ACID 1,1-DIOXIDE 76646-91-8 C8H9Br2NO5S
(S)-Citalopram N-Oxide (S)-Citalopram N-Oxide 917482-45-2 C20H21FN2O2
7-Epi-docetaxel (Docetaxel Impurity C) 7-Epi-docetaxel (Docetaxel Impurity C) 153381-68-1 C43H53NO14
Amido Methyl Meloxicam (Meloxicam Impurity) Amido Methyl Meloxicam (Meloxicam Impurity) 892395-41-4 C15H15N3O4S2
DESETHYLENE CIPROFLOXACIN DESETHYLENE CIPROFLOXACIN 103222-12-4 C15H16FN3O3
4-Nitrofluorobenzol 4-Nitrofluorobenzol 352-15-8 C6H4FNO
propyl[2,6'-bi-1H-benzimidazol]-1'-yl]methyl]- propyl[2,6'-bi-1H-benzimidazol]-1'-yl]methyl]- 144702-27-2 C33H29N5
4-(2-Hydroxy-3-isopropylaminopropoxy)benzoic Acid 4-(2-Hydroxy-3-isopropylaminopropoxy)benzoic Acid 72570-70-8 C13H19NO4
Fluvoxamino Acid Fluvoxamino Acid 192876-02-1 C14H19F3N2O2
Fluvastatin N-Ethyl Sodium Salt (Fluvastatin Impurity) Fluvastatin N-Ethyl Sodium Salt (Fluvastatin Impurity) 93936-64-2 C23H23FNNaO4
1-(4-hydroxy-2-methoxyphenyl)ethanone 1-(4-hydroxy-2-methoxyphenyl)ethanone 493-33-4 C9H10O3
3,5-androstadien-17-one 3,5-androstadien-17-one 1912-63-6 C19H26O
Decitabine iMpurity 5 Decitabine iMpurity 5
Erlotinib iMpurity 3 Erlotinib iMpurity 3 328528-74-1 C20H22BrN3O4
LevetiracetaM IMpurity 3 LevetiracetaM IMpurity 3 1543353-92-9 C8H15NO4
Sofosbuvir IMpurity Sofosbuvir IMpurity
(3R,4R,5R)-4-(1-Ethylpropoxy)-3-hydroxy-5-[(Methylsulfonyl)oxy]-1-cyclohexene-1-carboxylic Acid Ethyl Ester (3R,4R,5R)-4-(1-Ethylpropoxy)-3-hydroxy-5-[(Methylsulfonyl)oxy]-1-cyclohexene-1-carboxylic Acid Ethyl Ester 204254-94-4 C15H26O7S
9,11-Anhydrobudesonide 9,11-Anhydrobudesonide 313474-58-7 C25H32O5
iperazineacetic acid, 4-[(4- chlorophenyl)phenylMethyl]- iperazineacetic acid, 4-[(4- chlorophenyl)phenylMethyl]- 113740-61-7 C19H21ClN2O2
EveroliMus-d4 EveroliMus-d4 1338452-54-2 C53H79D4NO14
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