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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
door bird impurities door bird impurities
5H-Cyclohepta[b]pyridin-5-one, 6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-9-hydroxy-, (6S,9R)- 5H-Cyclohepta[b]pyridin-5-one, 6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-9-hydroxy-, (6S,9R)- 1289023-89-7 C16H13F2NO2
Topiroxostat Impurity 41 Topiroxostat Impurity 41
1-((2R,3R)-3-(4-(4-cyanophenyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-((methyl(3-((2-(methylamino)acetoxy)methyl)pyridin-1-oxide-2-yl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium 1-((2R,3R)-3-(4-(4-cyanophenyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-((methyl(3-((2-(methylamino)acetoxy)methyl)pyridin-1-oxide-2-yl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium
Cyclophosphamide Impurity 8 Cyclophosphamide Impurity 8 90632-33-0 C7H17N2O4P
2-Piperidinecarboxylic acid, 1-formyl-, (1S,2R,3S,6R,7E,10S,12S)-3-hydroxy-1-[(1E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethenyl]-12-methoxy-2,8,10-trimethyl-5-oxo-6-(2-propen-1-yl)-12-[(2R,3S,5R)-tetrahydro-3-methoxy-5-methyl-6-oxo-2H-pyra 2-Piperidinecarboxylic acid, 1-formyl-, (1S,2R,3S,6R,7E,10S,12S)-3-hydroxy-1-[(1E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethenyl]-12-methoxy-2,8,10-trimethyl-5-oxo-6-(2-propen-1-yl)-12-[(2R,3S,5R)-tetrahydro-3-methoxy-5-methyl-6-oxo-2H-pyra 143210-33-7 C43H69NO11
Blonanserin Impurity 15 Blonanserin Impurity 15 143213-96-1 C17H17ClFNO
Methanimidamide, N'-(2-cyano-4-nitrophenyl)-N,N-dimethyl-, (1E)- Methanimidamide, N'-(2-cyano-4-nitrophenyl)-N,N-dimethyl-, (1E)- 1203904-18-0 C10H10N4O2
1H-Pyrazole-1-propanoic acid, β-cyclopentyl-4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-, (βR)- 1H-Pyrazole-1-propanoic acid, β-cyclopentyl-4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-, (βR)- 2102675-40-9 C17H19N5O2
(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl ethyl sulfate (2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl ethyl sulfate
sodium ((S)-4-(4-(2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d] pyrimidin-5-yl)ethyl)benzamido)-4-carboxylatobutanoyl)-L-glutamate sodium ((S)-4-(4-(2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d] pyrimidin-5-yl)ethyl)benzamido)-4-carboxylatobutanoyl)-L-glutamate
1H-Purin-2-amine, 6,9-dihydro-9-[(1S,3R,4S)-2-methylene-4-(phenylmethoxy)-3-[(phenylmethoxy)methyl]cyclopentyl]-6-(phenylmethoxy)-N-(triphenylmethyl)- 1H-Purin-2-amine, 6,9-dihydro-9-[(1S,3R,4S)-2-methylene-4-(phenylmethoxy)-3-[(phenylmethoxy)methyl]cyclopentyl]-6-(phenylmethoxy)-N-(triphenylmethyl)- 2097265-84-2 C52H49N5O3
6,6'-oxybis(3-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzonitrile) 6,6'-oxybis(3-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzonitrile)
Glycine, N-[(1-ethyl-4-hydroxy-7-phenoxy-3-isoquinolinyl)carbonyl]- Glycine, N-[(1-ethyl-4-hydroxy-7-phenoxy-3-isoquinolinyl)carbonyl]- 808120-20-9 C20H18N2O5
Vonoprazan Impurity 55 Vonoprazan Impurity 55
N-(5-((diphenylphosphoryl)methyl)-4-(2-fluorophenyl)-6-isopropylpyrimidin-2-yl)-N-methylmethanesulfonamide N-(5-((diphenylphosphoryl)methyl)-4-(2-fluorophenyl)-6-isopropylpyrimidin-2-yl)-N-methylmethanesulfonamide
Ethane, 1,1,1-trichloro-2,2,2-trimethoxy- Ethane, 1,1,1-trichloro-2,2,2-trimethoxy- 19932-79-7 C5H9Cl3O3
Budesonide Impurity 29 Budesonide Impurity 29
GADOTERIDOL   RELATED  COMPOUND   B  (50 MG) (1,4,7,10-TETRAAZACYCLODODECANE-1,4,7-TRIACETIC ACID, MONOGADOLINIUM SALT) GADOTERIDOL RELATED COMPOUND B (50 MG) (1,4,7,10-TETRAAZACYCLODODECANE-1,4,7-TRIACETIC ACID, MONOGADOLINIUM SALT) 112188-16-6 C14H23GdN4O6
Edaravone Impurity Edaravone Impurity
1-Butanesulfonic acid, 4-hydroxy-, methyl ester 1-Butanesulfonic acid, 4-hydroxy-, methyl ester 343928-18-7 C5H12O4S
Fesoterodine Impurity 17 Fesoterodine Impurity 17
1-(4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzyl)-1,4,8,11-tetraazacyclotetradecane 1-oxide 1-(4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzyl)-1,4,8,11-tetraazacyclotetradecane 1-oxide C28H54N8O
Cabozantinib impurity DX2 Cabozantinib impurity DX2 1628530-38-0 C28H24FN3O6
Selegiline Impurity (224Da) Selegiline Impurity (224Da)
Oxybutynin Impurity(MW 481Da) Oxybutynin Impurity(MW 481Da)
Vitamin K1 hydroxylated Impurity Vitamin K1 hydroxylated Impurity
2,2'-(4,10-bis((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid 4HCl 2,2'-(4,10-bis((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid 4HCl
Cefdinir CP Impurity F Cefdinir CP Impurity F
Ceftazidime Oxide Impurity 1 Ceftazidime Oxide Impurity 1
Nifuratel Impurity 21 Nifuratel Impurity 21
Ornidazole Impurity 15 Ornidazole Impurity 15 105687-87-4 C7H9ClN4O5
2-(Dimethylamino)ethyl 4-methylbenzenesulfonate 2-(Dimethylamino)ethyl 4-methylbenzenesulfonate 123091-15-6 C11H17NO3S
Vildagliptin I Impurity Vildagliptin I Impurity 1811569-16-0 C7H9IN2O
Acemetacin EP Impurity D/6-t-Butyl Acemetacin/[[[1-(4-Chlorobenzoyl)-6-(1,1-dimethylethyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetyl]oxy]acetic acid Acemetacin EP Impurity D/6-t-Butyl Acemetacin/[[[1-(4-Chlorobenzoyl)-6-(1,1-dimethylethyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetyl]oxy]acetic acid 76812-64-1 C25H26ClNO6
Pregabalin Impurity 38 Pregabalin Impurity 38 1141362-94-8 C8H15NO2
Acemetacin Impurity D Acemetacin Impurity D
6,6'-oxybis(3-formylbenzonitrile) 6,6'-oxybis(3-formylbenzonitrile)
4-Ethyl-2,3-dioxo-N-phenylpiperazine-1-carboxamide 4-Ethyl-2,3-dioxo-N-phenylpiperazine-1-carboxamide 65322-79-4 C13H15N3O3
Cucurbitacin IIa 2-O-glucoside Cucurbitacin IIa 2-O-glucoside 77704-34-8 C38H60O13
Cabozantinib Impurity EXA Cabozantinib Impurity EXA 1431468-36-8 C17H14F2N2O2
Budesonide Impurity 20 Budesonide Impurity 20
5-Hexenoic acid, 4-(acetylamino)- 5-Hexenoic acid, 4-(acetylamino)- 1824506-31-1 C8H13NO3
Glycine, N-[(4-methylphenyl)sulfonyl]glycyl-, ethyl ester Glycine, N-[(4-methylphenyl)sulfonyl]glycyl-, ethyl ester 2478-45-7 C13H18N2O5S
Nandrolone cypionate Nandrolone cypionate 601-63-8 C26H38O3
Pneumocandin B0, 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N2-[(10R,12S)-10,12-dimethyl-1-oxotetradecyl]-4-hydroxy-L-ornithine]- Pneumocandin B0, 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N2-[(10R,12S)-10,12-dimethyl-1-oxotetradecyl]-4-hydroxy-L-ornithine]- 1404083-47-1 C52H86N10O16
1-Pyrrolidinehexanoic acid, 2-ethenyl-γ,5-dioxo- 1-Pyrrolidinehexanoic acid, 2-ethenyl-γ,5-dioxo- 2512190-67-7 C12H17NO4
2-Piperidinone, 3-chloro-1-(4-nitrophenyl)- 2-Piperidinone, 3-chloro-1-(4-nitrophenyl)- 2512213-45-3 C11H11ClN2O3
Avatrombopag Impurity 40 Avatrombopag Impurity 40
(E)-3-(4-((3-(1-(4-((1H-imidazol-1-yl)methyl)phenyl)-2-carboxyethyl)-1H-imidazol-3-ium-1-yl)methyl)phenyl)acrylate (E)-3-(4-((3-(1-(4-((1H-imidazol-1-yl)methyl)phenyl)-2-carboxyethyl)-1H-imidazol-3-ium-1-yl)methyl)phenyl)acrylate
Cisatracurium besylate impurity 21 Cisatracurium besylate impurity 21
Dacomitinib Impurity Dacomitinib Impurity
6-O-DESMETHYL DONEPEZIL 6-O-DESMETHYL DONEPEZIL 120013-56-1 C23H27NO3
2-(2-METHYL-4-NITRO-IMIDAZOL-1-YL)-ETHANOL 2-(2-METHYL-4-NITRO-IMIDAZOL-1-YL)-ETHANOL 705-19-1 C6H9N3O3
6-Chloro-6-defluoro Ciprofloxacin 6-Chloro-6-defluoro Ciprofloxacin 93106-58-2 C17H18ClN3O3
5-[(4-amino-2-carboxyphenyl)amino]-2-hydroxybenzoic acid 5-[(4-amino-2-carboxyphenyl)amino]-2-hydroxybenzoic acid 1797983-23-3 C14H12N2O5
4-[1-methoxy-2-(methylamino)ethyl]benzene-1,2-diol:hydrochloride 4-[1-methoxy-2-(methylamino)ethyl]benzene-1,2-diol:hydrochloride 74571-90-7 C10H15NO3.ClH
(1-methylpiperidin-4-yl)(pyridin-2-yl)methanone (1-methylpiperidin-4-yl)(pyridin-2-yl)methanone 517875-04-6 C12H16N2O
2-cyano-1,3-bis(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)guanidine 2-cyano-1,3-bis(2-(((5-methyl-1H-imidazol-4-yl)methyl)thio)ethyl)guanidine 55272-86-1 C16H24N8S2
3-(4-(4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxamido)piperidin-1-yl)propyl 4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxylate 3-(4-(4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxamido)piperidin-1-yl)propyl 4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxylate
4-{[(4-carboxybenzyl)amino]methyl}benzoic acid 4-{[(4-carboxybenzyl)amino]methyl}benzoic acid 14900-61-9 C16H15NO4
(1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2-(dimethylglycyl)-2,3,4,9-tetrahydro-1H-pyrido [3,4-b]indole-3-carboxylate methyl (1R,3R)-1-(benzo[d][1,3]dioxol-5-yl)-2-(dimethylglycyl)-2,3,4,9-tetrahydro-1H-pyrido [3,4-b]indole-3-carboxylate methyl 2169996-11-4 C24H25N3O5
Fulvestrant impurity G Fulvestrant impurity G
2-ethoxy-1-methoxy-4-(2-(methylsulfonyl)ethyl)benzene 2-ethoxy-1-methoxy-4-(2-(methylsulfonyl)ethyl)benzene C12H18O4S
Bendamustine Related Impurity 17 Bendamustine Related Impurity 17
Bortezomib Impurity 24 Bortezomib Impurity 24
Bortezomib Impurity 38 Bortezomib Impurity 38
Elagolix Sodium impurity4 Elagolix Sodium impurity4 2248628-92-2 C19H21NO4S
Tadalafil Impurity 45 Tadalafil Impurity 45
(R)-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-ol (R)-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-ol C28H28O3
(trans)-4-((2-amino-4,5-dibromobenzyl)amino)cyclohexanol (trans)-4-((2-amino-4,5-dibromobenzyl)amino)cyclohexanol C13H18Br2N2O
Tafluprost Impurity 13 Tafluprost Impurity 13
ISOPROMETHAZINE HYDROCHLORIDE ISOPROMETHAZINE HYDROCHLORIDE 5568-90-1 C17H21ClN2S
ZOLPIDEM IMPURITY A ZOLPIDEM IMPURITY A 1346600-85-8 C19H21N3O
Carbamic acid, N-[(1S,2S,4S)-2-hydroxy-4-[[(2-methylpropoxy)carbonyl]amino]-5-phenyl-1-(phenylmethyl)pentyl]-, 5-thiazolylmethyl ester Carbamic acid, N-[(1S,2S,4S)-2-hydroxy-4-[[(2-methylpropoxy)carbonyl]amino]-5-phenyl-1-(phenylmethyl)pentyl]-, 5-thiazolylmethyl ester 1010809-39-8 C28H35N3O5S
Piperazine, 1,4-bis[2-[(2,4-dimethylphenyl)thio]phenyl]- Piperazine, 1,4-bis[2-[(2,4-dimethylphenyl)thio]phenyl]- 2243045-82-9 C32H34N2S2
2-amino-4-methoxy-5-(3-morpholin-4-ylpropoxy)benzoic acid 2-amino-4-methoxy-5-(3-morpholin-4-ylpropoxy)benzoic acid 1640351-46-7 C15H22N2O5
3-Desoxyvitamin D3 3-Desoxyvitamin D3 69662-75-5 C27H44
cis-Vitamin K2 cis-Vitamin K2 65061-19-0 C31H40O2
N,N'-((5-methylisoxazole-3,4-diyl)bis(3,1-phenylenesulfonyl))dipropionamide disodium salt N,N'-((5-methylisoxazole-3,4-diyl)bis(3,1-phenylenesulfonyl))dipropionamide disodium salt
Zanubrutinib Impurity Zanubrutinib Impurity 3104323-56-7
(O-Isobutyryl (R)-Fesoterodine (O-Isobutyryl (R)-Fesoterodine 1795786-25-2 C30H43NO4
Cefdinir Degradation Impurity 1 Cefdinir Degradation Impurity 1
Cephalexin Impurity C2 Cephalexin Impurity C2
Cefalexin Ethyl Homolog 2 Impurity Cefalexin Ethyl Homolog 2 Impurity
Azlocillin Opern-Ring Impurity Azlocillin Opern-Ring Impurity 96688-41-4 C20H25N5O7S
Piperacillin Impurity P Piperacillin Impurity P
1,1'-(((2R,2'R,4R,4'R)-4,4'-(oxybis(methylene))bis(2-(2,4-difluoro phenyl)tetrahydrofuran-4,2-diyl))bis(methylene))bis(1H-1,2,4-triazole) 1,1'-(((2R,2'R,4R,4'R)-4,4'-(oxybis(methylene))bis(2-(2,4-difluoro phenyl)tetrahydrofuran-4,2-diyl))bis(methylene))bis(1H-1,2,4-triazole) 2256739-22-5 C28H28F4N6O3
8-((R)-1-acryloylpiperidin-3-yl)-10-(4-phenoxyphenyl)-1,10b-dihydropyrazolo[4,3-e]pyrimido[1,2-c]pyrimidin-2(8H)-one 8-((R)-1-acryloylpiperidin-3-yl)-10-(4-phenoxyphenyl)-1,10b-dihydropyrazolo[4,3-e]pyrimido[1,2-c]pyrimidin-2(8H)-one
Levosimendan Impurity 16 Levosimendan Impurity 16 2290570-69-1 C11H12N2O
Tolvaptan Impurity 11 Tolvaptan Impurity 11 331947-69-4 C16H14ClNO2
(S)-2-((R)-2,5-dioxo-3-propylpyrrolidin-1-yl)butanamide (S)-2-((R)-2,5-dioxo-3-propylpyrrolidin-1-yl)butanamide 2432911-31-2 C11H18N2O3
(S)-N-((S)-1-amino-1-oxobutan-2-yl)-3-(bromomethyl)hexanamide (S)-N-((S)-1-amino-1-oxobutan-2-yl)-3-(bromomethyl)hexanamide
Peramivir Impurity 17 Peramivir Impurity 17
Peramivir Impurity 23 Peramivir Impurity 23
Silodosin Carboxylic Acid Impurity Silodosin Carboxylic Acid Impurity 1431373-77-1 C25H31F3N2O5
Vigabatrin Impurity 1 Vigabatrin Impurity 1 2324151-81-5 C8H11NO3
Pramipexole Impurity M Pramipexole Impurity M
Premastast Impurity 2 Premastast Impurity 2
Cyclopentolate Impurity Cyclopentolate Impurity 36882-00-5 C12H17NO2
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