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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
Ertapenem Impurity I(USP) Ertapenem Impurity I(USP)
Acetonitrile, (3,4-dihydro-7-methoxy-1(2H)-naphthalenylidene)-, (Z)- (9CI) Acetonitrile, (3,4-dihydro-7-methoxy-1(2H)-naphthalenylidene)-, (Z)- (9CI) 178676-66-9 C13H13NO
Aflatoxin Aflatoxin 1402-68-2 C17H14O6.C17H14O7.C17H12O6.C17H12O7
Penicillin EP  Impurity A Penicillin EP Impurity A
Voriconzolegenotoxicimpurity Voriconzolegenotoxicimpurity
N4,N7-bis(3-chloro-4-fluorophenyl)-8-nitroquinazoline-4,7-diamine N4,N7-bis(3-chloro-4-fluorophenyl)-8-nitroquinazoline-4,7-diamine
1H-Benzimidazole-2-butanoic acid, 5-[(2-hydroxyethyl)amino]-1-methyl- 1H-Benzimidazole-2-butanoic acid, 5-[(2-hydroxyethyl)amino]-1-methyl- 956344-27-7 C14H19N3O3
Iohexol ImpuritiesD Iohexol ImpuritiesD
ethyl (Z)-3-(4-((1H-imidazol-1-yl)methyl)phenyl)acrylate ethyl (Z)-3-(4-((1H-imidazol-1-yl)methyl)phenyl)acrylate
2-Demethoxy-2-chloro Urapidil HCl 2-Demethoxy-2-chloro Urapidil HCl
Isavuconazole Impurity 43 Isavuconazole Impurity 43
Elagolix Impurity 41 Elagolix Impurity 41
Benzeneacetic acid, α-hydroxy-, (1R,5R)-3,3,5-trimethylcyclohexyl ester, (αR)-rel- Benzeneacetic acid, α-hydroxy-, (1R,5R)-3,3,5-trimethylcyclohexyl ester, (αR)-rel- 79356-86-8 C17H24O3
Ethyl (2E)-3-[4-(Dibromomethyl)phenyl]prop-2-enoate Ethyl (2E)-3-[4-(Dibromomethyl)phenyl]prop-2-enoate
8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)-1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)-1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine
	Bumetanide Impurity 18 Bumetanide Impurity 18
Cefradine Impurity J Cefradine Impurity J
N-Desmethyl Clarithromycin N-Desmethyl Clarithromycin 101666-68-6 C37H67NO13
Rocuronium Bromide Impurity 19 、21、22 Rocuronium Bromide Impurity 19 、21、22
Flucloxacillin impurity D Flucloxacillin impurity D
Ritonavir EP Impurity STU Ritonavir EP Impurity STU
Letermovir Impurity 1 Letermovir Impurity 1
Roxadustat Impurity 16 Roxadustat Impurity 16
Perospirone Impurity 19 Perospirone Impurity 19
Dolutegravir Impurity 14(Sodium Salt) Dolutegravir Impurity 14(Sodium Salt)
Fondaparinux sodium impurity 5 Fondaparinux sodium impurity 5
Fondaparinux sodium impurity 20 Fondaparinux sodium impurity 20
Piperacillin  Impurity R Piperacillin Impurity R
Lasmiditan Impurity 6 Lasmiditan Impurity 6
1-methylpyrrolidin-3-yl 2-(4-chlorophenyl)-2-cyclopentyl- 2-hydroxyacetate hydrochloride 1-methylpyrrolidin-3-yl 2-(4-chlorophenyl)-2-cyclopentyl- 2-hydroxyacetate hydrochloride
Lasmiditan Impurity 8 Lasmiditan Impurity 8
1-methyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl) piperazine 1-oxide dihydrate 1-methyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl) piperazine 1-oxide dihydrate 2760465-02-7 C17H22N4O2S
Ethacridine Impurity 10 Ethacridine Impurity 10 20304-71-6 C21H16N2O4
(S)-N-(1-Azabicyclo[2.2.2]oct-3-yl)-5,6,7,8-tetrahydro-1-naphthalenecarboxamide (S)-N-(1-Azabicyclo[2.2.2]oct-3-yl)-5,6,7,8-tetrahydro-1-naphthalenecarboxamide 135729-78-1 C18H24N2O
2-(2-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid 2-(2-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid
Olodaterol Impurity 31 Olodaterol Impurity 31
(S)-N-[(2S,4S,5S)-5-Amino-4-hydroxy-1,6-diphenylhexan-2-yl]-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide (S)-N-[(2S,4S,5S)-5-Amino-4-hydroxy-1,6-diphenylhexan-2-yl]-3-methyl-2-(2-oxotetrahydropyrimidin-1(2H)-yl)butanamide 192726-05-9 C27H38N4O3
2-Hydrazinoadenosine 2-Hydrazinoadenosine 15763-11-8 C10H15N7O4
Oseltamivir Impurity 126 Oseltamivir Impurity 126
2H-1,4-Benzoxazin-3(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-hydroxyphenyl)-1,1-dimethylethyl]amino]ethyl]-, hydrochloride (1:1) 2H-1,4-Benzoxazin-3(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-hydroxyphenyl)-1,1-dimethylethyl]amino]ethyl]-, hydrochloride (1:1) 936490-85-6 C20H25ClN2O5
Desacetylvinblastine hydrazide Desacetylvinblastine hydrazide 55383-37-4 C43H56N6O7
4-hydroxypyrrolidin-2-one 4-hydroxypyrrolidin-2-one 96820-00-7 C4H7NO2
glycopyrronium bromide glycopyrronium bromide 475468-09-8 C19H28NO3.Br
Acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)imino]-3,4,5,6,7,8-hexahydro-8-hydroxy-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]- Acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)imino]-3,4,5,6,7,8-hexahydro-8-hydroxy-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]- 1383430-03-2 C26H23FIN5O5
protosappanin A protosappanin A 102036-28-2 C15H12O5
BENAZEPRILAT BENAZEPRILAT 86541-78-8 C22H24N2O5
9-Methylene-9H-fluorene 9-Methylene-9H-fluorene 4425-82-5 C14H10
7-cyclopentyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid hydrochloride 7-cyclopentyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid hydrochloride
2-PIPERIDIN-4-YL-1H-BENZOIMIDAZOLE 2-PIPERIDIN-4-YL-1H-BENZOIMIDAZOLE 38385-95-4 C12H15N3
4-CHLORO-3,5-DIMETHYL 2-CHLORMETHYL PYRIDINE.HCL 4-CHLORO-3,5-DIMETHYL 2-CHLORMETHYL PYRIDINE.HCL 142885-96-9 C8H9Cl2N
9-DIHYDROESTRADIOL 9-DIHYDROESTRADIOL 791-69-5 C18H22O2
(2S,3S,5S)-5-[(N-Formyl-L-leucyl)oxy]-2-hexyl-3-hydroxyhexadecanoic Acid (Orlistat Impurity) (2S,3S,5S)-5-[(N-Formyl-L-leucyl)oxy]-2-hexyl-3-hydroxyhexadecanoic Acid (Orlistat Impurity) 130676-66-3 C29H55NO6
2-(2-Fluoro-4-iodo-aniline)-4-hydroxy-1, 5-dimethyl-6-oxo-1,6-dihydro-pyridine-3-carboxylic acid cyclopropylamide 2-(2-Fluoro-4-iodo-aniline)-4-hydroxy-1, 5-dimethyl-6-oxo-1,6-dihydro-pyridine-3-carboxylic acid cyclopropylamide 3018911-27-5 C17H17FIN3O3
Pramipexole EP Impurity E Pramipexole EP Impurity E 106006-84-2 C10H15N3OS
3-Anilino-2-(3,4,5-triMethoxybenzyl)acrylonitrile, (Mixture of cis/trans isoMers) 3-Anilino-2-(3,4,5-triMethoxybenzyl)acrylonitrile, (Mixture of cis/trans isoMers) 30078-48-9 C19H20N2O3
1,2-Benzenediol, 4-(1-hydroxyethyl)- 1,2-Benzenediol, 4-(1-hydroxyethyl)- 37491-94-4 C8H10O3
Acetamide, 2-(diethylamino)-N-(3,4-dimethylphenyl)- Acetamide, 2-(diethylamino)-N-(3,4-dimethylphenyl)- 3213-16-9 C14H22N2O
(trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4'-fluoro-[1,1'- biphenyl]-4-yl)piperidine (trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4'-fluoro-[1,1'- biphenyl]-4-yl)piperidine 1217975-87-5 C25H24FNO3
Carboprost Impurity 1 Carboprost Impurity 1
Beraprost Impurity 1 Beraprost Impurity 1
Org246653-1(RRT0.31) Org246653-1(RRT0.31)
Linagliptin impurity Linagliptin impurity
CEFMETAZOLE IMPURITY CEFMETAZOLE IMPURITY 76952-82-4 C13H16N6O5S3
Acyclovir impurity R Acyclovir impurity R
Ornidazole Impurity 7 Ornidazole Impurity 7 109620-80-6 C6H8ClN3O3
(1R,2S,5aS,6aS,7aR,8aS,10aS) (1R,2S,5aS,6aS,7aR,8aS,10aS)
(E)-8-(3,4-dihydroxystyryl) (E)-8-(3,4-dihydroxystyryl)
N,N'-((2Z,2'Z)-disulfanediylbis N,N'-((2Z,2'Z)-disulfanediylbis
Cabozantinib impurity 1DYH Cabozantinib impurity 1DYH 1621681-63-7 C28H24FN3O6
1-((2R,3R)-3-(2,3-dihydrobenzo[b] 1-((2R,3R)-3-(2,3-dihydrobenzo[b] 2137145-62-9 C23H36N2O5
Tiotropium Bromide Impurity 1 Tiotropium Bromide Impurity 1 2109037-83-2 C18H20ClNO4S2
Dofetilide Impurity A Dofetilide Impurity A
Sugammadex disulfide Impurity Sugammadex disulfide Impurity
Reference Material for the Calibration of Urine Analyzer Reference Material for the Calibration of Urine Analyzer
Hispidulin 4'-O-β-D-glucopyranoside Hispidulin 4'-O-β-D-glucopyranoside 244285-12-9 C22H22O11
Dexmedetomidine Impurity 19 Dexmedetomidine Impurity 19
Voriconazole Impurity 18 Voriconazole Impurity 18 321588-94-7 C22H18ClF4N7O
Remdesivir impurity Remdesivir impurity 1911578-74-9 C12H14N5O7P
ethyl 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4- (phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan- 4-yl)acetate ethyl 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4- (phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan- 4-yl)acetate 616201-27-5 C38H43FN2O5
Peramivir Impurity 16 Peramivir Impurity 16
Tiotropium bromide Impurity 13 Tiotropium bromide Impurity 13 1459721-06-2 C18H19NO4S2
Anastrozole Impurity I Anastrozole Impurity I
Anastrozole Impurity I Anastrozole Impurity I
Fluconazole impurity I(For Chinese Pharmacopiea) Fluconazole impurity I(For Chinese Pharmacopiea)
Rocuronium bromide diepoxide impurity Rocuronium bromide diepoxide impurity C21H30O4
2-hydroxy-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzonitrile 2-hydroxy-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzonitrile
6-Methoxykaempferol 3-O-glucoside 6-Methoxykaempferol 3-O-glucoside 63422-27-5 C22H22O12
Topiroxostat Impurity 39 Topiroxostat Impurity 39
4'-hydroxyflurbiprofen 4'-hydroxyflurbiprofen 52807-12-2 C15H13FO3
D-biotin-d-sulfoxide D-biotin-d-sulfoxide 10406-89-0 C10H16N2O4S
3,4-dihydroxyphenylpyruvic acid 3,4-dihydroxyphenylpyruvic acid 4228-66-4 C9H8O5
Imimidistine impurity E Imimidistine impurity E
delta(3)-cefotiam delta(3)-cefotiam 142182-63-6 C18H23N9O4S3
anemonin anemonin 508-44-1 C10H8O4
alpha-(chloromethyl)-2-hydroxymethyl-5-nitroimidazole-1-ethanol alpha-(chloromethyl)-2-hydroxymethyl-5-nitroimidazole-1-ethanol 62580-79-4 C7H10ClN3O4
7-(deoxyadenosin-N(6)-yl)aristolactam I 7-(deoxyadenosin-N(6)-yl)aristolactam I 127191-86-0 C27H22N6O7
(3S,4S,5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)tetrahydrofuran-2-yl acetate (3S,4S,5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)tetrahydrofuran-2-yl acetate 2875066-46-7 C16H17F5O4
(1R,2S)-2-[[(2,4-Dimethyl-5-pyrimidinyl)oxy]methyl]-2-(3-fluorophenyl)-N-2-pyridinylcyclopropanecarboxamide (1R,2S)-2-[[(2,4-Dimethyl-5-pyrimidinyl)oxy]methyl]-2-(3-fluorophenyl)-N-2-pyridinylcyclopropanecarboxamide 1369763-94-9 C22H21FN4O2
Nemonoxacin Impurity 5 Nemonoxacin Impurity 5 2770004-79-8 C24H29N3O8
4-hydroxypenicillin V 4-hydroxypenicillin V 20880-67-5 C16H18N2O6S
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