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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
Levocarnitine Impurity F Levocarnitine Impurity F 6490-19-3 C7H17ClN2O2
4,4-dimethyl-2-(2-phenylpropan-2-yl)oxazo‐ line 4,4-dimethyl-2-(2-phenylpropan-2-yl)oxazo‐ line 874895-87-1 C14H19NO
Formoterol Impurity 4 Formoterol Impurity 4
3β,7β,19-Trihydroxy-25-methoxycucurbita-5,23-diene 7-O-glucoside 3β,7β,19-Trihydroxy-25-methoxycucurbita-5,23-diene 7-O-glucoside 81910-37-4 C37H62O9
Roxadustat-001 Roxadustat-001 319-57-3 C8H5BF4N2O2
Ornidazole Impurity 24 Ornidazole Impurity 24
Olanzapine impurity ANB Olanzapine impurity ANB
Pitavastatin Impurity 75 Pitavastatin Impurity 75
Febuxostat Impurity 100 Febuxostat Impurity 100
Febuxostat Impurity 101 Febuxostat Impurity 101
Febuxostat Impurity 105 Febuxostat Impurity 105
(S)-10-amino-9-fluoro-3-methyl-7-oxo-3,7-dihydro-2H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid (S)-10-amino-9-fluoro-3-methyl-7-oxo-3,7-dihydro-2H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid
Ticagrelor Impurity 129 Ticagrelor Impurity 129 1381841-36-6 C15H19NO3
Benzoic acid, 2-hydroxy-3-(2-phenyldiazenyl)- Benzoic acid, 2-hydroxy-3-(2-phenyldiazenyl)- 136819-59-5 C13H10N2O3
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-, 5-oxide, (6R,7R)- (9CI) 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-, 5-oxide, (6R,7R)- (9CI) 97466-28-9 C18H18N8O8S3
1,3-Benzenediamine, 4-methyl-N3-[4-methyl-6-(3-pyridinyl)-2-pyrimidinyl]- 1,3-Benzenediamine, 4-methyl-N3-[4-methyl-6-(3-pyridinyl)-2-pyrimidinyl]- 1032314-73-0 C17H17N5
5-methoxy-1-methyl-1H-benzo[d]imidazole-2-sulfonic acid 5-methoxy-1-methyl-1H-benzo[d]imidazole-2-sulfonic acid
Teneligliptin Impurity 17 Teneligliptin Impurity 17
Ethanone, 2-bromo-1-(5-bromo-4-chloro-2-thienyl)- Ethanone, 2-bromo-1-(5-bromo-4-chloro-2-thienyl)- 1519427-10-1 C6H3Br2ClOS
1(3H)-Isobenzofuranone, 3-(1-methylpropyl)- 1(3H)-Isobenzofuranone, 3-(1-methylpropyl)- 261783-87-3 C12H14O2
(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl methyl sulfate (2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl methyl sulfate
Carbamic acid, N-[(1R)-2-[5-(2-fluoro-3-hydroxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3,6-dihydro-4-methyl-2,6-dioxo-1(2H)-pyrimidinyl]-1-phenylethyl]-, 1,1-dimethylethyl ester Carbamic acid, N-[(1R)-2-[5-(2-fluoro-3-hydroxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3,6-dihydro-4-methyl-2,6-dioxo-1(2H)-pyrimidinyl]-1-phenylethyl]-, 1,1-dimethylethyl ester 1062642-68-5 C32H30F5N3O5
2-Oxazolidinone, 5-(2,2-dimethyl-4H-1,3-benzodioxin-6-yl)-, (5S)- 2-Oxazolidinone, 5-(2,2-dimethyl-4H-1,3-benzodioxin-6-yl)-, (5S)- 2514942-86-8 C13H15NO4
Heptanoic acid, 7-[[(3R,5R)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxy-1-oxoheptyl]amino]-3,5-dihydroxy-, 1,1-dimethylethyl ester, (3R,5R)- Heptanoic acid, 7-[[(3R,5R)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxy-1-oxoheptyl]amino]-3,5-dihydroxy-, 1,1-dimethylethyl ester, (3R,5R)- 2409556-65-4 C44H56FN3O8
6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-5-hydroxy-3-oxo-, (5S,6E)- 6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-5-hydroxy-3-oxo-, (5S,6E)- 1803023-43-9 C22H26FN3O6S
Drug impurity detection and analysis Drug impurity detection and analysis
1-Pyrrolidinecarboxamide, N-[5-[(2S)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl]-3-hydroxy-, (3R)- 1-Pyrrolidinecarboxamide, N-[5-[(2S)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl]-3-hydroxy-, (3R)- 2409590-08-3 C21H22F2N6O2
Sertraline Impurity 20 Sertraline Impurity 20 1498236-91-1 C16H14Cl2O
Budesonide Impurity 21 Budesonide Impurity 21
2H-3-Benzazepin-2-one, 3-(3-bromopropyl)-1,3,4,5-tetrahydro-7,8-dimethoxy- 2H-3-Benzazepin-2-one, 3-(3-bromopropyl)-1,3,4,5-tetrahydro-7,8-dimethoxy- 1192174-72-3 C15H20BrNO3
Benzamide, 2-[(1-acetyl-3-iodo-1H-indazol-6-yl)thio]-N-methyl- Benzamide, 2-[(1-acetyl-3-iodo-1H-indazol-6-yl)thio]-N-methyl- 1639138-00-3 C17H14IN3O2S
2-Pyrrolidinone, 3-ethylidene- 2-Pyrrolidinone, 3-ethylidene- 27428-45-1 C6H9NO
1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-nitro-, ethyl ester, (3R,4R,5S)- 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-nitro-, ethyl ester, (3R,4R,5S)- 949164-64-1 C16H26N2O6
Peramivir Impurity 55 Peramivir Impurity 55
Peramivir Impurity 60 Peramivir Impurity 60
Hexanoic acid, 3-(hydroxymethyl)-, methyl ester, (3R)- Hexanoic acid, 3-(hydroxymethyl)-, methyl ester, (3R)- 2408196-94-9 C8H16O3
Loratadine EP Impurity L Loratadine EP Impurity L
(E)-2-CYANO-5-METHYL-HEX-2-ENOIC ACID METHYL ESTER (E)-2-CYANO-5-METHYL-HEX-2-ENOIC ACID METHYL ESTER 96914-67-9 C9H13NO2
Nicergoline Impurity 7 Nicergoline Impurity 7
N,N'-Bis(2-Hydroxyethyl)propane-1,3-diamine N,N'-Bis(2-Hydroxyethyl)propane-1,3-diamine 10563-27-6 C7H18N2O2
4-((3-hydroxy-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one 4-((3-hydroxy-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one
2-oxo-2-((6S,8S,9S,10R,13S,14S,17S)-6,10,13-trimethyl-3,11-dioxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)ethyl acetate 2-oxo-2-((6S,8S,9S,10R,13S,14S,17S)-6,10,13-trimethyl-3,11-dioxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)ethyl acetate
Tirofiban Impurity 79 Tirofiban Impurity 79 158808-85-6 C21H34N2O5S
Brivaracetam Impurity 47 Brivaracetam Impurity 47 2755924-55-9
(Glu3)-Carbetocin (Impurity D) (Glu3)-Carbetocin (Impurity D)
4-((3-amino-1-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoyl)-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one 4-((3-amino-1-(2-fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoyl)-1H-indazol-5-yl)methyl)phthalazin-1(2H)-one
(Z)-[cyano(2,3-dichlorophenyl)methylene]carbazamidine (Z)-[cyano(2,3-dichlorophenyl)methylene]carbazamidine 94213-23-7 C9H7Cl2N5
Perampanel Impurity ABCDEFGHJKL Perampanel Impurity ABCDEFGHJKL
1-deoxy-1-[2-(phenylazo)-3,4-xylidino]-D-ribitol 1-deoxy-1-[2-(phenylazo)-3,4-xylidino]-D-ribitol 21037-25-2 C19H25N3O4
ethyl 3-acetoxy-2-butenoate ethyl 3-acetoxy-2-butenoate 29214-62-8 C8H12O4
2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-methanol 2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-methanol 68751-57-5 C11H11BrCl2O3
2H-3-Benzazepin-2-one, 3-[3-[[[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-1-hydroxy-7,8-dimethoxy- 2H-3-Benzazepin-2-one, 3-[3-[[[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-1-hydroxy-7,8-dimethoxy- 2511244-96-3 C27H36N2O6
Oseltamivir  Impurity 91 Oseltamivir Impurity 91
Oseltamivir  Impurity 80 Oseltamivir Impurity 80
Mirabegron iMpurity Mirabegron iMpurity 1581285-26-8 C16H21ClN2
Sunitinib iMpurity Sunitinib iMpurity 356068-98-9 C12H19N3O2
(-)-DihydroapovincaMinic Acid Ethyl Ester (-)-DihydroapovincaMinic Acid Ethyl Ester 57327-92-1 C22H28N2O2
(α1S,α4S,2S,5S)-2,5-DiMethyl-3,6-dioxo-α1,α4-bis(2-phenylethyl)-1,4-piperazinediacetic Acid 1,4-Diethyl Ester (α1S,α4S,2S,5S)-2,5-DiMethyl-3,6-dioxo-α1,α4-bis(2-phenylethyl)-1,4-piperazinediacetic Acid 1,4-Diethyl Ester 151387-05-2 C30H38N2O6
[2-(4-Fluorophenyl)cyclopropyl]aMine hydrochloride [2-(4-Fluorophenyl)cyclopropyl]aMine hydrochloride 879324-66-0 C9H11ClFN
[4-(4-AMino-7-hydroxy-6-Methoxy-2-quinazolinyl)-1-piperazinyl](tetrahydro-2-furanyl)Methanone [4-(4-AMino-7-hydroxy-6-Methoxy-2-quinazolinyl)-1-piperazinyl](tetrahydro-2-furanyl)Methanone 105356-90-9 C18H23N5O4
2-(DiethylaMino)-N-(2,5-diMethylphenyl)acetaMide Hydrochloride 2-(DiethylaMino)-N-(2,5-diMethylphenyl)acetaMide Hydrochloride 1012864-23-1 C14H23ClN2O
2-Keto-D-gulonic Acid Methyl Ester 2-Keto-D-gulonic Acid Methyl Ester 67776-07-2 C7H12O7
9,11-Dehydro-17α-cyanoMethyl Estradiol 9,11-Dehydro-17α-cyanoMethyl Estradiol 86153-38-0 C20H23NO2
DeMethyl Irbesartan DeMethyl Irbesartan 158778-58-6 C24H26N6O
Epiprednisolone Epiprednisolone 600-90-8 C21H28O5
δ-2-CefodiziMe (2 :1 Mixture) δ-2-CefodiziMe (2 :1 Mixture) 120533-30-4 C20H20N6O7S4
Salbutamol Acetonide Salbutamol Acetonide 54208-72-9 C16H25NO3
8-Chloro-1-methyl-6-phenyl-4H-Imidazo[1,5-a][1,4]benzodiazepine 8-Chloro-1-methyl-6-phenyl-4H-Imidazo[1,5-a][1,4]benzodiazepine 59467-86-6 C18H14ClN3
BenzeneMethanaMine, 4-ethoxy-3-Methoxy-a-[(Methylsulfonyl)Methyl]- BenzeneMethanaMine, 4-ethoxy-3-Methoxy-a-[(Methylsulfonyl)Methyl]- 885268-06-4 C12H19NO4S
Afatinib IMpurity C Afatinib IMpurity C
Afatinib IMpurity C Afatinib IMpurity C
AMisulpride IMpurity AMisulpride IMpurity 84859-26-7 C8H17NO2
Avanafil iMpurity 5 Avanafil iMpurity 5
Cefoxitin iMpurity E (R-Methoxy cefoxitin) Cefoxitin iMpurity E (R-Methoxy cefoxitin)
Desloratadine IMpurity 3 Desloratadine IMpurity 3 1346600-61-0 C19H19ClN2
DibroMo IMpurity DibroMo IMpurity 1352492-08-0 C15H12Br2O2
ErtapeneM IMpurity DIPP ErtapeneM IMpurity DIPP 220031-86-7 C18H27N2O6PS
Gefitinib IMpurity 1 Gefitinib IMpurity 1 1561173-24-7 C15H22ClN3O3
Pitavastatin Defuoro IMpurity CalciuM Salt Pitavastatin Defuoro IMpurity CalciuM Salt 1258947-30-6 C50H50CaN2O8
Solifenacin Related CoMpound 4 Succinate Solifenacin Related CoMpound 4 Succinate 862207-71-4 C27H32N2O6
Pregna-1,4-dien-3-one, 21-(acetyloxy)-11,17,20-trihydroxy-6-methyl-, (6α,11β)- (9CI) Pregna-1,4-dien-3-one, 21-(acetyloxy)-11,17,20-trihydroxy-6-methyl-, (6α,11β)- (9CI) 151003-82-6 C24H34O6
3-Pyridinecarboxamide, 5-chloro-N-[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]-1,6-dihydro-6-oxo- 3-Pyridinecarboxamide, 5-chloro-N-[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]-1,6-dihydro-6-oxo- 762237-66-1 C23H25Cl2N5O2S2
3-(4-TRIFLUOROMETHYL-PHENYL)-PROPAN-1-OL 3-(4-TRIFLUOROMETHYL-PHENYL)-PROPAN-1-OL 180635-74-9 C10H11F3O
Avatrombopag Impurity 39 Avatrombopag Impurity 39
(1R,2R)-2-(3-((5-acetoxypentyl)oxy)-3-oxopropyl)-1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-2-ium (1R,2R)-2-(3-((5-acetoxypentyl)oxy)-3-oxopropyl)-1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolin-2-ium
Oseltamivir  Impurity 72 Oseltamivir Impurity 72
4(1H)-Quinazolinone, 6,8-dibromo-3-cyclohexyl-2,3-dihydro- 4(1H)-Quinazolinone, 6,8-dibromo-3-cyclohexyl-2,3-dihydro- 2512203-87-9 C14H16Br2N2O
Linagliptin impurity KH-3 Linagliptin impurity KH-3 2279114-27-9 C30H37N7O6
4-Imidazolidinone, 2,5-dimethyl-3-(2-methylphenyl)-1-propyl- 4-Imidazolidinone, 2,5-dimethyl-3-(2-methylphenyl)-1-propyl- 780037-66-3 C15H22N2O
3-Azetidineacetic acid, 1-(ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]-, methyl ester 3-Azetidineacetic acid, 1-(ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]-, methyl ester 2402776-80-9 C17H20N6O4S
Ampicillin Impurity U Ampicillin Impurity U
Canagliflozin Hydroperoxide Impurity Canagliflozin Hydroperoxide Impurity
(E)-2-hydroxy-4-(phenyldiazenyl)benzoic acid (E)-2-hydroxy-4-(phenyldiazenyl)benzoic acid 40038-46-8 C13H10N2O3
Sitagliptin EP Impurity 6 Sitagliptin EP Impurity 6
Vonoprazan-005 Vonoprazan-005 2514735-09-0 C33H27F3N4
D-erythro-Hexonic acid, 6-S-2-benzothiazolyl-2,4-dideoxy-6-thio-, 1,1-dimethylethyl ester D-erythro-Hexonic acid, 6-S-2-benzothiazolyl-2,4-dideoxy-6-thio-, 1,1-dimethylethyl ester 1469771-46-7 C17H23NO4S2
(1R,2R,4S,5S,7s,9R)-9-butyl-7-(((S)-3-hydroxy-2-phenylpropanoyl)oxy)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium bromide (1R,2R,4S,5S,7s,9R)-9-butyl-7-(((S)-3-hydroxy-2-phenylpropanoyl)oxy)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium bromide
Propanoic acid, 2,2-dimethyl-, 2-chloroethyl ester Propanoic acid, 2,2-dimethyl-, 2-chloroethyl ester 51479-37-9 C7H13ClO2
1-Demethyl Hydroxy Daunomycinone 1-Demethyl Hydroxy Daunomycinone 58199-98-7 C20H16O9
(S)-2-(butylsulfonamido)-3-(4-(4-(1-methylpiperidin-4-yl)butoxy)phenyl)propanoic acid (S)-2-(butylsulfonamido)-3-(4-(4-(1-methylpiperidin-4-yl)butoxy)phenyl)propanoic acid 1631053-75-2 C23H38N2O5S
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