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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
1H-Pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline, 2,3,6b,7,8,9,10,10a-octahydro-, (6bR,10aS)- 1H-Pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline, 2,3,6b,7,8,9,10,10a-octahydro-, (6bR,10aS)- 313368-81-9 C13H17N3
Ergoline-8-methanol, 1,6-dimethyl-, (8β)- (9CI) Ergoline-8-methanol, 1,6-dimethyl-, (8β)- (9CI) 40170-12-5 C17H22N2O
Avatrombopag Impurity 22 Avatrombopag Impurity 22
Avatrombopag Impurity 33 Avatrombopag Impurity 33
Cisatracurium besylate impurity 16 Cisatracurium besylate impurity 16
Afatinib impurity 84 Afatinib impurity 84
Sugammadex sodium Impurity 40 Sugammadex sodium Impurity 40
Sugammadex sodium Impurity 44 Sugammadex sodium Impurity 44
Sugammadex sodium Impurity 49 Sugammadex sodium Impurity 49
Cefazolin Impurity EP-E Cefazolin Impurity EP-E
Canagliflozin Impurity 70 Canagliflozin Impurity 70
Dapoxetine impurity 66 Dapoxetine impurity 66
EP Impurity Catalog EP Impurity Catalog
Gadobutrol Impurity 3 Gadobutrol Impurity 3 2227984-48-5
Empagliflozin Impurity 84 Empagliflozin Impurity 84
Octreotide  (Dimer, Antiparallel) Octreotide (Dimer, Antiparallel) 1926163-78-1 C98H132N20O20S4
Iohexol Impurity O Iohexol Impurity O
Avibactam sodium Impurity CES Avibactam sodium Impurity CES
Bis{2-[benzyl(methyl)amino]ethyl} 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate dihydrochloride Bis{2-[benzyl(methyl)amino]ethyl} 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate dihydrochloride 71784-27-5 C35H41ClN4O6
3-amino-6-chloro-2-methyl-4-phenylquinazolin-4-ol 3-amino-6-chloro-2-methyl-4-phenylquinazolin-4-ol 27537-87-7 C15H14ClN3O
Riluzole 5-Trifluoromethoxy Isomer Riluzole 5-Trifluoromethoxy Isomer 752969-85-0 C8H5F3N2OS
Pazufloxacin Impurity 7 Pazufloxacin Impurity 7 171567-48-9 C15H15FN2O3
Empagliflozin Impurity 42 Empagliflozin Impurity 42
2-amino-2-(4-nonylphenethyl)propane-1,3-diol 2-amino-2-(4-nonylphenethyl)propane-1,3-diol 746594-44-5 C20H35NO2
Zopiclone Impurity 17 Zopiclone Impurity 17
(2,5-dichlorophenyl)(4-ethoxyphenyl)methanone (2,5-dichlorophenyl)(4-ethoxyphenyl)methanone 1097076-93-1 C15H12Cl2O2
Lenvatinib impurity LFZZ-10 Lenvatinib impurity LFZZ-10 C11H8Cl2N2O2
(2S,5S)-(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl 5-(4-amino-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylate (2S,5S)-(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl 5-(4-amino-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2-carboxylate
Febuxostat Impurity 98 Febuxostat Impurity 98
(2-(methyl((vinyloxy)carbonyl)amino)pyridin-3-yl)methyl 2-(methylamino)acetate hydrochloride (2-(methyl((vinyloxy)carbonyl)amino)pyridin-3-yl)methyl 2-(methylamino)acetate hydrochloride
1-(4-bromo-3,5-dimethoxyphenyl)ethanone 1-(4-bromo-3,5-dimethoxyphenyl)ethanone 1333472-28-8 C10H11BrO3
Ticagrelor Impurity 117 Ticagrelor Impurity 117
Ticagrelor Impurity 136 Ticagrelor Impurity 136
Phenol, 2-(diphenylmethyl)-5-methyl- Phenol, 2-(diphenylmethyl)-5-methyl- 411239-19-5 C20H18O
1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-(formylamino)-, ethyl ester, (3R,4R,5S)- 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-(formylamino)-, ethyl ester, (3R,4R,5S)- 2148317-96-6 C17H28N2O5
Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-(5-chloro-2-ethoxyphenyl)-5-methyl-7-propyl- Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-(5-chloro-2-ethoxyphenyl)-5-methyl-7-propyl- 2245167-80-8 C17H19ClN4O2
Posaconazole impurity 18 Posaconazole impurity 18 1819334-66-1 C44H49F2N8O4+
(4S,6R)-6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxane-4-carboxylic acid (4S,6R)-6-(2-(tert-butoxy)-2-oxoethyl)-2,2-dimethyl-1,3-dioxane-4-carboxylic acid 2095786-11-9 C13H22O6
Crisaborole intermediate Crisaborole intermediate 2354382-27-5 C14H8BCl2NO3
Ropivacaine Impurity 48 Ropivacaine Impurity 48
2(1H)-Pyridinone, 1,1'-[(1E)-1,2-diazenediyldi-4,1-phenylene]bis[5,6-dihydro-3-(4-morpholinyl)- 2(1H)-Pyridinone, 1,1'-[(1E)-1,2-diazenediyldi-4,1-phenylene]bis[5,6-dihydro-3-(4-morpholinyl)- 1998079-15-4 C30H34N6O4
2,4-Heptadienoic acid, 7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-, (2Z,4E)- 2,4-Heptadienoic acid, 7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-, (2Z,4E)- 1148131-09-2 C33H31FN2O3
2(3H)-Furanone, dihydro-4-(1-methylethyl)-, (4S)- 2(3H)-Furanone, dihydro-4-(1-methylethyl)-, (4S)- 53657-15-1 C7H12O2
IRAS vials are low alkaline and meet the pharmacopoeia standards of various countries IRAS vials are low alkaline and meet the pharmacopoeia standards of various countries
Crisaborole Impurity 9 HCl Crisaborole Impurity 9 HCl 1187187-01-4 C14H15BClNO3
2H-Indol-2-one, 3-[[3,5-dimethyl-4-(1-pyrrolidinylcarbonyl)-1H-pyrrol-2-yl]methylene]-5-fluoro-1,3-dihydro- 2H-Indol-2-one, 3-[[3,5-dimethyl-4-(1-pyrrolidinylcarbonyl)-1H-pyrrol-2-yl]methylene]-5-fluoro-1,3-dihydro- 2135339-43-2 C20H20FN3O2
Nicergoline Impurity 02 Nicergoline Impurity 02
Bromhexine ImpurityABCDEFGHJKL Bromhexine ImpurityABCDEFGHJKL
1-Butanone, 1-(4-fluorophenyl)-4-[(6bR,10aR)-2,3,6b,9,10,10a-hexahydro-3-methyl-1H-pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl]- 1-Butanone, 1-(4-fluorophenyl)-4-[(6bR,10aR)-2,3,6b,9,10,10a-hexahydro-3-methyl-1H-pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl]- 1576240-16-8 C24H28FN3O
impurity 37 impurity 37
Aprepitant impurity 3 Aprepitant impurity 3
sodium (6R,7S)-7-(2-(1H-tetrazol-1-yl)acetamido)-3-(((5-methyl- 1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate sodium (6R,7S)-7-(2-(1H-tetrazol-1-yl)acetamido)-3-(((5-methyl- 1,3,4-thiadiazol-2-yl)thio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
2(1H)-Pyridinone, 1-(4-aminophenyl)-3-chloro-5,6-dihydro- 2(1H)-Pyridinone, 1-(4-aminophenyl)-3-chloro-5,6-dihydro- 1801881-15-1 C11H11ClN2O
1,4,7,10-Tetraazacyclododecane-1,4-diacetic acid 1,4,7,10-Tetraazacyclododecane-1,4-diacetic acid 229312-34-9 C12H24N4O4
Pregabalin Impurity D Pregabalin Impurity D 53439-96-6 C11H14O3
Cephalosporin Impurity 3 HCl Cephalosporin Impurity 3 HCl 2429-86-9 C14H17N3O6S
((2R,3S,4R,5R,6S)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl) methyl)-4-methylphenyl)-3,4,5-trihydroxytetrahydro- 2H-pyran-2-yl)methyl acetate ((2R,3S,4R,5R,6S)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl) methyl)-4-methylphenyl)-3,4,5-trihydroxytetrahydro- 2H-pyran-2-yl)methyl acetate 2146135-87-5 C26H27FO6S
Atracurium Impurity 5 Atracurium Impurity 5
Cefazolin Impurity 1 Cefazolin Impurity 1
Tofacitinib Impurity 77 Tofacitinib Impurity 77 1640971-51-2 C16H20N6O2
Tofacitinib Impurity 84 Tofacitinib Impurity 84
Cetirizine impurity B 2HCl Cetirizine impurity B 2HCl 1000690-91-4 C19H22Cl2N2O2
7-Despropyl 7-Methyl Vardenafil 7-Despropyl 7-Methyl Vardenafil 2169247-39-4 C21H28N6O4S
Apixaban Impurity 32 Apixaban Impurity 32
Apremilast Impurity 20 Apremilast Impurity 20
Bendamustine Impurity 36 Bendamustine Impurity 36
Bosutinib Impurity 7 Bosutinib Impurity 7 219786-51-3 C10H12BrNO4
Cefazolin Impurity 13 Cefazolin Impurity 13 1607841-65-5 C25H24N12O6S6
Cefoxitin Impurity 4 Cefoxitin Impurity 4
Ceftizoxime Impurity 19 Ceftizoxime Impurity 19 64918-77-0 C7H8N2O4S
Cilnidipine Impurity 3 Cilnidipine Impurity 3 123853-41-8 C24H22N2O6
Erlotinib Impurity 50 Erlotinib Impurity 50
Pitavastatin Impurity 26 Pitavastatin Impurity 26
Plerixafor Impurity 2 Plerixafor Impurity 2
Pregabalin Impurity 48 Pregabalin Impurity 48 1239856-83-7 C11H23NO2
Rivaroxaban Impurity 76 Rivaroxaban Impurity 76
Rocuronium bromide Impurity 36 Rocuronium bromide Impurity 36
Sildenafil Impurity 14 Sildenafil Impurity 14 2146091-79-2 C24H32N6OS2
Telmisartan Impurity 6 Telmisartan Impurity 6 1083158-65-9 C19H22N4O
Apremilast Impurity CNA Apremilast Impurity CNA
Atracurium Impurity Q Atracurium Impurity Q
Atracurium Impurity W Atracurium Impurity W
AZD9291(Osimertinib) Impurity 5 AZD9291(Osimertinib) Impurity 5
Azilsartan impurity Y Azilsartan impurity Y
Celecoxib Impurity 15 Celecoxib Impurity 15 C17H14F3N3O2S
Etoposide Impurity 2 Etoposide Impurity 2
Fludarabine EP impurity J Fludarabine EP impurity J
Ropivacaine Impurity 12 Ropivacaine Impurity 12
Solifenacin impurity 17 Solifenacin impurity 17 1029430-94-1 C19H17N3O
Sugammadex sodium Org205485-1 Impurity Sugammadex sodium Org205485-1 Impurity
Sugammadex sodium Org246653-1 Impurity Sugammadex sodium Org246653-1 Impurity
Tadalafil impurity R Tadalafil impurity R
N-((4-(5-(p-tolyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)phenyl) sulfonyl)acetamide N-((4-(5-(p-tolyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)phenyl) sulfonyl)acetamide 198471-47-5 C19H16F3N3O3S
Afatinib impurity 35 Afatinib impurity 35
Avibactam Impurity 40 Avibactam Impurity 40 2089462-89-3 C15H20N2O3
Butyphthalide impurity 29 Butyphthalide impurity 29
Butyphthalide impurity 38 Butyphthalide impurity 38 1841089-56-2 C24H30O5
Canagliflozin Impurity 39 Canagliflozin Impurity 39
Cefaclor double bond displacement impurity 9 Cefaclor double bond displacement impurity 9
Diquafosol Impurity 7 Diquafosol Impurity 7
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