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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
Peramivir Impurity 8 Peramivir Impurity 8
Pitavastatin Impurity 13 Pitavastatin Impurity 13
Pramipexole Impurity R Pramipexole Impurity R
Tadalafil Impuirty 21 Tadalafil Impuirty 21
3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-2-[1-[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]pentan-2-yl]-1,3-diazaspiro[4.4]non-1-en-4-one 3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-2-[1-[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]pentan-2-yl]-1,3-diazaspiro[4.4]non-1-en-4-one 1346598-52-4 C39H38N10O
1,11-ditosyl-1,4,8,11-tetraazacyclotetradecane dihydrochloride 1,11-ditosyl-1,4,8,11-tetraazacyclotetradecane dihydrochloride 117152-73-5 C24H36N4O4S2
PeraMpanel PeraMpanel 684648-40-6 C10H10BNO2
3-CHLORO-N-(3-METHOXYPHENYL)PROPANAMIDE 3-CHLORO-N-(3-METHOXYPHENYL)PROPANAMIDE 21261-76-7 C10H12ClNO2
Amlodipine Impurity 31 Amlodipine Impurity 31 496024-43-2 C20H22ClNO5
Fudosteine Impurity 5 Fudosteine Impurity 5
Rasagiline Impurity 4 Rasagiline Impurity 4 1175018-79-7 C12H14ClN
CAPECITABINE-D11 CAPECITABINE-D11 1132662-08-8 C15H13D11FN3O6
Piperacillin Impurity N Piperacillin Impurity N
2-(1-(dimethylamino)ethyl)phenol 2,3-dihydroxysuccinate 2-(1-(dimethylamino)ethyl)phenol 2,3-dihydroxysuccinate 26050-44-2 C10H15NO
Miconazole EP Impurity F Miconazole EP Impurity F 47447-55-2 C18H14Cl4N2O
Raltegravir USP RC E Raltegravir USP RC E 1193687-87-4 C20H22N6O5
Vigabatrin EP Impurity F Vigabatrin EP Impurity F 794466-81-2 C12H20N2O3
Dehydronitrosonisoldipine Dehydronitrosonisoldipine 87375-91-5 C20H22N2O5
Brexpiprazole Impurity 49 Brexpiprazole Impurity 49 1700655-67-9 C13H14N2O2S
Etoricoxib Impurity 38 Etoricoxib Impurity 38 887479-63-2 C13H17NO2S
Pemetrexed Impurity 19 Pemetrexed Impurity 19 1644286-36-1 C20H21N5O8
Empagliflozin Impurity 31 Empagliflozin Impurity 31
Iguratimod Iguratimod 123663-50-3 C18H16N2O6S
1,4-bis(4-((1,4,8,11-tetraazacyclotetradecan-4,8,11-trifluoroacetyl- 1-yl)methyl)benzyl)-8,11-difluoroacetyl-1,4,8,11-tetraazacyclotetra decane 1,4-bis(4-((1,4,8,11-tetraazacyclotetradecan-4,8,11-trifluoroacetyl- 1-yl)methyl)benzyl)-8,11-difluoroacetyl-1,4,8,11-tetraazacyclotetra decane
Imidafenacin Related Compound 10 Imidafenacin Related Compound 10 212756-27-9 C21H23N3O
Aprepitant Aprepitant 1242175-36-5 C20H18F7NO2
Idebenone Impurity 5 Idebenone Impurity 5 88543-33-3 C18H28O5
Entacapone Impurity 4 Entacapone Impurity 4 1202160-40-4 C11H8N2O6
L-Leucine, N-formyl-, (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]tridecyl ester L-Leucine, N-formyl-, (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]tridecyl ester 1119226-56-0 C30H55NO5
Itraconazole Impurity 17 Itraconazole Impurity 17 854372-78-4 C14H15Cl2N3O5S
sodium (41S,12R,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12, 13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5] naphthyridine-12-carboxylate sodium (41S,12R,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12, 13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5] naphthyridine-12-carboxylate 53448-45-6 C20H24N2O3
Rivaroxaban Impurity 35 Rivaroxaban Impurity 35 2206360-74-7 C23H24N4O6
Tirofiban hydrochloride monohydrate Impurity 7 Tirofiban hydrochloride monohydrate Impurity 7 2250244-28-9 C13H19NO5S
Acarbose Impurity G Acarbose Impurity G
Imidafenacin Related Compound 7 Imidafenacin Related Compound 7 191592-57-1 C16H13N
17β-Cyanmethyl-oestra-1,3,5(10)-trien-3,17β-diol 17β-Cyanmethyl-oestra-1,3,5(10)-trien-3,17β-diol 16669-06-0 C20H25NO2
Cefaclor Impurity 6 Cefaclor Impurity 6
Cephalexin Impurity 6 Cephalexin Impurity 6 C16H17N3O4S
Pitavastatin Impurity 42 Pitavastatin Impurity 42
Rocuronium bromide Impurity J Rocuronium bromide Impurity J C32H53BrN2O4
Tofacitinib Impurity 72 Tofacitinib Impurity 72
Tofacitinib Impurity 81 Tofacitinib Impurity 81
Topiroxostat Impurity 9 Topiroxostat Impurity 9 2044708-04-3 C7H10N6O
Vinorelbine EP Impurity C Vinorelbine EP Impurity C
2-Benzylidene isobutyryl acetanilide 2-Benzylidene isobutyryl acetanilide 125971-57-5 C19H19NO2
ISOPROPYLAMINE HYDROCHLORIDE ISOPROPYLAMINE HYDROCHLORIDE 15572-56-2 C3H10ClN
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[[(aminocarbonyl)oxy]methyl]-7-methoxy-7-[[(2S)-2-methoxy-2-(2-thienyl)acetyl]amino]-8-oxo-, (6R,7S)- 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[[(aminocarbonyl)oxy]methyl]-7-methoxy-7-[[(2S)-2-methoxy-2-(2-thienyl)acetyl]amino]-8-oxo-, (6R,7S)- 2395025-37-1 C17H19N3O8S2
Atorvastatin Impurity 83 Atorvastatin Impurity 83 1807481-00-0 C33H35F2N2NaO5
Loteprednol Etabonate Ethyl Ester (Prednisolone 20-Ethyl Ester) Loteprednol Etabonate Ethyl Ester (Prednisolone 20-Ethyl Ester) 182069-19-8 C25H34O7
Hexanamide, N-[(1S)-1-(aminocarbonyl)propyl]-3-(hydroxymethyl)-, (3R)- Hexanamide, N-[(1S)-1-(aminocarbonyl)propyl]-3-(hydroxymethyl)-, (3R)- 2252417-17-5 C11H22N2O3
1H-Benzimidazole-6-carboxylic acid, 4-hydroxy-2-methyl-1-(phenylmethyl)-, ethyl ester 1H-Benzimidazole-6-carboxylic acid, 4-hydroxy-2-methyl-1-(phenylmethyl)-, ethyl ester 1640981-16-3 C18H18N2O3
Benzoic acid, 2-chloro-4-nitro-, 2-(diethylamino)ethyl ester Benzoic acid, 2-chloro-4-nitro-, 2-(diethylamino)ethyl ester 10367-96-1 C13H17ClN2O4
(2R,3S)-3-amino-2-((Z)-2-(2-aminothiazol-4-yl)-2-(((2-carboxypropan-2-yl)oxy)imino)acetamido)butanoic acid (2R,3S)-3-amino-2-((Z)-2-(2-aminothiazol-4-yl)-2-(((2-carboxypropan-2-yl)oxy)imino)acetamido)butanoic acid
(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl isopropyl sulfate (2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl isopropyl sulfate
(S)-3-Methyl-1-(2-piperidin-1-ylphenyl)butylamine (S)-3-Methyl-1-(2-piperidin-1-ylphenyl)butylamine 147769-93-5 C16H26N2
2-CHLORO-N-(2,3-DIMETHYL-PHENYL)-ACETAMIDE 2-CHLORO-N-(2,3-DIMETHYL-PHENYL)-ACETAMIDE 2564-07-0 C10H12ClNO
1,4-dihydro-2,6-dimethyl-4-(3'-nitrophenyl)-pyridine-3,5-dicarboxylic acid monoisopropyl ester 1,4-dihydro-2,6-dimethyl-4-(3'-nitrophenyl)-pyridine-3,5-dicarboxylic acid monoisopropyl ester 116983-17-6 C18H20N2O6
Cabozantinib impurity 37 Cabozantinib impurity 37
4-(1-bromoethyl)-6-(1-(6-chloro-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidine 4-(1-bromoethyl)-6-(1-(6-chloro-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidine
ethyl 6-bromo-4,7-bis((dimethylamino)methyl)-5-hydroxy-1-methyl-2-((phenylthio)methyl)-1H-indole-3-carboxylate ethyl 6-bromo-4,7-bis((dimethylamino)methyl)-5-hydroxy-1-methyl-2-((phenylthio)methyl)-1H-indole-3-carboxylate
Dapoxetine impurity 53 Dapoxetine impurity 53
Apigenin 4'-O-(2'',6''-di-O-E-p-coumaroyl)glucoside Apigenin 4'-O-(2'',6''-di-O-E-p-coumaroyl)glucoside 71781-79-8 C39H32O14
Dapoxetine impurity 70 Dapoxetine impurity 70
Bosutinib Impurity 38 Bosutinib Impurity 38 2095306-26-4 C46H44Cl4N8O6
(E)-(3,4-Dihydro-7-methoxy-1(2H)-naphthalenylidene)acetonitrile (E)-(3,4-Dihydro-7-methoxy-1(2H)-naphthalenylidene)acetonitrile 178676-65-8 C13H13NO
3-[(2-[(E)-2-(3-ETHYL-1,3-BENZOTHIAZOL-3-IUM-2-YL)ETHENYL]-6-((E)-2-[3-ETHYL-1,3-BENZOTHIAZOL-2(3H)-YLIDENE]ETHYLIDENE)-4-METHYL-1-CYCLOHEXEN-1-YL)OXY]-1-PROPANESULFONATE 3-[(2-[(E)-2-(3-ETHYL-1,3-BENZOTHIAZOL-3-IUM-2-YL)ETHENYL]-6-((E)-2-[3-ETHYL-1,3-BENZOTHIAZOL-2(3H)-YLIDENE]ETHYLIDENE)-4-METHYL-1-CYCLOHEXEN-1-YL)OXY]-1-PROPANESULFONATE C32H36N2O4S3
Bimatoprost Impurity 15 Bimatoprost Impurity 15
Bisoprolol Impurity 9 Bisoprolol Impurity 9 59383-52-7 C15H25NO3
Empagliflozin Impurity 87 Empagliflozin Impurity 87
Amoxicillin USP Impurity M Amoxicillin USP Impurity M
Aztreonam Impurities 06 Aztreonam Impurities 06 730928-60-6 C26H34N10O16S4
sodium (4-(2-(2-amino-1-methyl-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d] pyrimidin-5-yl)ethyl)benzoyl)-L-glutamate sodium (4-(2-(2-amino-1-methyl-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d] pyrimidin-5-yl)ethyl)benzoyl)-L-glutamate
Lenvatinib Impurity LFZZ-9 Lenvatinib Impurity LFZZ-9 C43H38Cl2N8O8
Rosuvastatin Impurity 118 Rosuvastatin Impurity 118
Rosuvastatin Impurity 117 Rosuvastatin Impurity 117
Cytarabine Impurity 10 Cytarabine Impurity 10 84902-98-7 C4H6N2O3
Ticagrelor Impurity 108 Ticagrelor Impurity 108
4-Piperidinecarboxylic acid, 1-[5-[[[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]amino]carbonyl]-3-hydroxy-2-pyridinyl]- 4-Piperidinecarboxylic acid, 1-[5-[[[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]amino]carbonyl]-3-hydroxy-2-pyridinyl]- 1290121-42-4 C29H35ClN6O4S2
1,?4-?Piperazinediacetamid?e, N1,?N4-?dimethyl-?N1,?N4-?bis(4-?nitrophenyl)?- 1,?4-?Piperazinediacetamid?e, N1,?N4-?dimethyl-?N1,?N4-?bis(4-?nitrophenyl)?- 2410649-54-4 C22H26N6O6
1H-Pyrrole-3-methanamine, 1-[(1,6-dihydro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)-N-methyl- 1H-Pyrrole-3-methanamine, 1-[(1,6-dihydro-3-pyridinyl)sulfonyl]-5-(2-fluorophenyl)-N-methyl- 2416241-95-5 C17H18FN3O2S
Dolutegravir Impurity 8 Dolutegravir Impurity 8 2244161-72-4 C20H19F2N3O5
3-((2-((tert-butoxycarbonyl)(methyl)amino)acetoxy)methyl)-2-(((1-chloroethoxy)carbonyl)(methyl)amino)pyridine 1-oxide 3-((2-((tert-butoxycarbonyl)(methyl)amino)acetoxy)methyl)-2-(((1-chloroethoxy)carbonyl)(methyl)amino)pyridine 1-oxide
Benzenepropanoic acid, 2,4-dichloro-α-[(dimethylamino)methylene]-3-methyl-β-oxo-, ethyl ester Benzenepropanoic acid, 2,4-dichloro-α-[(dimethylamino)methylene]-3-methyl-β-oxo-, ethyl ester 2241304-69-6 C15H17Cl2NO3
Benzonitrile, 4-[3-[(acetyloxy)methyl]-4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenoxy]- Benzonitrile, 4-[3-[(acetyloxy)methyl]-4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenoxy]- 2227126-13-6 C22H24BNO5
(Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl] carbamoyl]methylene]amino]oxy]-2-methylpropionic acid methyl ester (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl] carbamoyl]methylene]amino]oxy]-2-methylpropionic acid methyl ester 1255912-98-1 C14H19N5O8S2
Benzeneacetic acid, α-1-cyclopenten-1-yl-α-hydroxy-, (αR)- Benzeneacetic acid, α-1-cyclopenten-1-yl-α-hydroxy-, (αR)- 185030-09-5 C13H14O3
1-Piperazinecarboxaldehyde, 4-cyclohexyl- 1-Piperazinecarboxaldehyde, 4-cyclohexyl- 2325305-38-0 C11H20N2O
1H-Pyrrole-1-acetic acid, α-ethyl-2,5-dihydro-2-oxo-4-propyl-, (αS)- 1H-Pyrrole-1-acetic acid, α-ethyl-2,5-dihydro-2-oxo-4-propyl-, (αS)- 2170761-55-2 C11H17NO3
Revefenacin ImpurityABCDEFGHJKL Revefenacin ImpurityABCDEFGHJKL
Peramivir Impurity 57 Peramivir Impurity 57
2-Thiazolamine, 4-(5-bromo-4-chloro-2-thienyl)- 2-Thiazolamine, 4-(5-bromo-4-chloro-2-thienyl)- 1534575-19-3 C7H4BrClN2S2
NA NA
BrivaracetamImpurity ABCDEFGHJKL BrivaracetamImpurity ABCDEFGHJKL
DEHYDRO FELODIPINE-13C4 DEHYDRO FELODIPINE-13C4 96382-71-7 C18H17Cl2NO4
Avatrombopag Impurity 24 Avatrombopag Impurity 24
(S)-2-(4-(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)-N-methylbenzamido)benzamido)pentanedioic acid (S)-2-(4-(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)-N-methylbenzamido)benzamido)pentanedioic acid
Cisatracurium besylate impurity 20 Cisatracurium besylate impurity 20 96946-54-2 C59H77N2O15S+
N-Desmethylondansetron N-Desmethylondansetron 99614-14-9 C17H17N3O
CHEMPACIFIC 59929 CHEMPACIFIC 59929 856240-62-5 C18H24O4
Linagliptin ImpurityABCDEF Linagliptin ImpurityABCDEF
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