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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
Crisaborole intermediate Crisaborole intermediate 1187230-70-1 C14H14BNO3
Glycine, (2R)-N-[(4-ethyl-2,3-dioxo-1-piperazinyl)carbonyl]-2-phenylglycyl-2-[(2S,4S)-4-carboxy-5,5-dimethyl-2-thiazolidinyl]-, (2R)- Glycine, (2R)-N-[(4-ethyl-2,3-dioxo-1-piperazinyl)carbonyl]-2-phenylglycyl-2-[(2S,4S)-4-carboxy-5,5-dimethyl-2-thiazolidinyl]-, (2R)- 1449784-97-7 C23H29N5O8S
6-Quinolinecarboxamide, 4-[(2-chloro-4-hydroxyphenyl)amino]-7-methoxy- 6-Quinolinecarboxamide, 4-[(2-chloro-4-hydroxyphenyl)amino]-7-methoxy- 2380197-89-5 C17H14ClN3O3
1-Pyrrolidineacetic acid, α-ethyl-2-oxo-4-propyl-, methyl ester, (4R)- 1-Pyrrolidineacetic acid, α-ethyl-2-oxo-4-propyl-, methyl ester, (4R)- 930123-52-7 C12H21NO3
Traxipide impurity Traxipide impurity
Benzeneacetic acid, 4-[2-[4-[1-(2-ethoxyethyl)-1H-benzimidazol-2-yl]-1-piperidinyl]ethyl]-α,α-dimethyl-, methyl ester Benzeneacetic acid, 4-[2-[4-[1-(2-ethoxyethyl)-1H-benzimidazol-2-yl]-1-piperidinyl]ethyl]-α,α-dimethyl-, methyl ester 1181267-38-8 C29H39N3O3
Benzenemethanol, 4-[2-(1-methylethoxy)ethoxy]- Benzenemethanol, 4-[2-(1-methylethoxy)ethoxy]- 1039828-27-7 C12H18O3
Brivaracetam Impurity 7 HCl Brivaracetam Impurity 7 HCl 357338-46-6 C13H27ClN2O3
Bisacodyl Impurity 1 Bisacodyl Impurity 1 13004-51-8 C18H15NO2
Vecuronium Bromide ImpurityACDEFGHJKL Vecuronium Bromide ImpurityACDEFGHJKL
Butanedioic acid, 2-[[2-methyl-1-(phenylmethyl)-1H-imidazol-5-yl]methylene]-, 1-ethyl ester, (2E)- Butanedioic acid, 2-[[2-methyl-1-(phenylmethyl)-1H-imidazol-5-yl]methylene]-, 1-ethyl ester, (2E)- 1640981-02-7 C18H20N2O4
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2452300-94-4 C21H25ClO8
1-Butanone, 1-(4-fluorophenyl)-4-[(6bS,10aS)-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-[(6bS,10aS)-2,3,6b,9,10,10a-hexahydro-3-methyl-1H-pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl]- 1576240-15-7 C24H28FN3O
1-Pyrrolidineacetamide, α-ethyl-4-(1-methylethyl)-2-oxo-, (αS,4S)- 1-Pyrrolidineacetamide, α-ethyl-4-(1-methylethyl)-2-oxo-, (αS,4S)- 357334-83-9 C11H20N2O2
impurity 42 impurity 42
2,2'-(4,10-bis((2S,3R)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid 2,2'-(4,10-bis((2S,3R)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid
Loratadine Impurity 2 Loratadine Impurity 2 167891-69-2 C22H25ClN2O2
Eliglustat (1S,2S)-Isomer (Hemitartrate) Eliglustat (1S,2S)-Isomer (Hemitartrate) 1092472-70-2 C23H36N2O4
Voriconazole Impurity 19 Voriconazole Impurity 19 321589-01-9 C26H28F3N5O4S
Salbutamol Impurity 38 Salbutamol Impurity 38
Gadobutrol Impurity 4 (Gd-DOTA) Gadobutrol Impurity 4 (Gd-DOTA)
Losartan Impurity 3 Losartan Impurity 3
methyl 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 methyl 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 1353049-81-6 C37H41FN2O5
Cilastatin EP Impurity G Cilastatin EP Impurity G
Rosuvastatin Impurity 122 Rosuvastatin Impurity 122 135999-58-5 C6H7ClO3
Anastrozole Impurity IV Anastrozole Impurity IV
Anastrozole Impurity IV Anastrozole Impurity IV
Modafinil Impurity B (Modafinil Sulfone) Modafinil Impurity B (Modafinil Sulfone)
Perindopril Impurity III (Perindoprilat), formerly known as: Perindopril Impurity S9780 (Perindoprilat) Perindopril Impurity III (Perindoprilat), formerly known as: Perindopril Impurity S9780 (Perindoprilat)
Tinidazole Impurity B Tinidazole Impurity B
Juncusol 7-O-glucoside Juncusol 7-O-glucoside 175094-15-2 C24H28O7
4-Allyl-2,6-dimethoxyphenyl glucoside 4-Allyl-2,6-dimethoxyphenyl glucoside 100187-70-0 C17H24O8
Apremilast Impurity 19 Apremilast Impurity 19 2201974-01-6 C22H24N2O7S
Nimodipine Metabolite 3 Nimodipine Metabolite 3 82219-48-5 C20H22N2O7
Osimertinib Impurity M Osimertinib Impurity M 1975982-94-5 C28H33N7O3
N-DEMETHYLROXITHROMYCIN N-DEMETHYLROXITHROMYCIN 118267-18-8 C40H74N2O15
Androst-2-en-17-one, (5β)- Androst-2-en-17-one, (5β)- 82467-84-3 C19H28O
Peramivir Impurity 21 Peramivir Impurity 21
Dapagliflozin Impurity 165 Dapagliflozin Impurity 165 342043-51-0 C18H18O4
3'-Desethoxy Drotaverine Hydrochloride 3'-Desethoxy Drotaverine Hydrochloride 85475-87-2 C22H28ClNO4
(S)-dimethyl 2-(4-(4-oxobutyl)benzamido)pentanedioate (S)-dimethyl 2-(4-(4-oxobutyl)benzamido)pentanedioate 1081974-98-2 C18H23NO6
Peramivir Impurity 38 Peramivir Impurity 38
2-O-cinnamoyl-beta-D-glucose 2-O-cinnamoyl-beta-D-glucose
(3S)-3-((S)-1-oxo-3a,4,5,6-tetrahydro-1H-benzo[de]isoquinolin-2(3H)-yl)quinuclidine 1-oxide (3S)-3-((S)-1-oxo-3a,4,5,6-tetrahydro-1H-benzo[de]isoquinolin-2(3H)-yl)quinuclidine 1-oxide
2-(4-hydroxy-1-methyl-7-phenoxy-5,6,7,8-tetrahydroisoquinoline-3-carboxamido)acetic acid 2-(4-hydroxy-1-methyl-7-phenoxy-5,6,7,8-tetrahydroisoquinoline-3-carboxamido)acetic acid
6-HYDROXYLAMINOURACIL 6-HYDROXYLAMINOURACIL 20555-88-8 C4H5N3O2
Dapagliflozin Dapagliflozin 639852-30-5 C19H44O5Si4
Cabozantinib impurity 52 Cabozantinib impurity 52
Canagliflozin Impurity 71 Canagliflozin Impurity 71
N-((4-(5-methyl-2-phenyloxazol-4-yl)phenyl)sulfonyl)propionamide N-((4-(5-methyl-2-phenyloxazol-4-yl)phenyl)sulfonyl)propionamide 2242749-02-4 C19H18N2O4S
Dapoxetine impurity 67 Dapoxetine impurity 67
3-Azetidineacetic acid, 1-(ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]- 3-Azetidineacetic acid, 1-(ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]- 2271228-52-3 C16H18N6O4S
Cyclopentanecarboxylic acid, 3-[(1S)-1-amino-2-ethylbutyl]-4-[(aminoiminomethyl)amino]-2-hydroxy-, (1S,2S,3S,4R)- Cyclopentanecarboxylic acid, 3-[(1S)-1-amino-2-ethylbutyl]-4-[(aminoiminomethyl)amino]-2-hydroxy-, (1S,2S,3S,4R)- 2412376-06-6 C13H26N4O3
Peramivir Impurity 49 Peramivir Impurity 49 2758048-81-4
(R)-(R)-1-methylpyrrolidin-3-yl 2-cyclopentyl-2-hydroxy-2-phenylacetate(WXC03446) (R)-(R)-1-methylpyrrolidin-3-yl 2-cyclopentyl-2-hydroxy-2-phenylacetate(WXC03446) 616866-21-8 C18H25NO3
(R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzoic acid (R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzoic acid C18H22N4O4
(R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzoic acid (R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzoic acid C18H22N4O4
6'-methyl-3-(4-(methylsulfonyl)phenyl)-[2,3'-bipyridin]-5-amine 6'-methyl-3-(4-(methylsulfonyl)phenyl)-[2,3'-bipyridin]-5-amine C18H17N3O2S
Diquafosol Impurity 4 Diquafosol Impurity 4
Tofacitinib Impurity X Tofacitinib Impurity X
3-pentylideneisobenzofuran-1(3H)-one 3-pentylideneisobenzofuran-1(3H)-one 90965-68-7 C13H14O2
Labetalol EP impurity E Labetalol EP impurity E
1-Propanol, 3-(2-methoxy-5-nitrophenoxy)- 1-Propanol, 3-(2-methoxy-5-nitrophenoxy)- 1156068-41-5 C10H13NO5
1616710-52-1 1616710-52-1 1616710-52-1 C27H34N2O6
Bendamustine Related Impurity 22 Bendamustine Related Impurity 22
Bendamustine Related Impurity 9 Bendamustine Related Impurity 9
Edoxaban Impurity 20 (1R,2R,4S) Edoxaban Impurity 20 (1R,2R,4S) 1928729-31-0 C16H29N3O7
Edoxaban Impurity 40 Edoxaban Impurity 40 2081883-52-3 C14H27N3O3
Everolimus Impurity 2 Everolimus Impurity 2
Levosimendan Impurity 2 (Mixture ofZandEIsomers) Levosimendan Impurity 2 (Mixture ofZandEIsomers)
N-(2,3-Dichloro-phenyl)-N'-[2-(2,3-dichloro-phenylamino)-ethyl]-ethane-1,2-diamine N-(2,3-Dichloro-phenyl)-N'-[2-(2,3-dichloro-phenylamino)-ethyl]-ethane-1,2-diamine C16H17Cl4N3
N-(2,3-Dichloro-phenyl)-N'-[2-(2,3-dichloro-phenylamino)-ethyl]-ethane-1,2-diamine N-(2,3-Dichloro-phenyl)-N'-[2-(2,3-dichloro-phenylamino)-ethyl]-ethane-1,2-diamine C16H17Cl4N3
Solifenacin Related Compound 29 Solifenacin Related Compound 29 861998-77-8 C23H26N2O3
Ticagrelor Impurity 31 Ticagrelor Impurity 31
Ticagrelor Related Compound 46 Ticagrelor Related Compound 46 2205903-73-5 C28H42ClN9O8S2
Ticagrelor Related Compound 71 Ticagrelor Related Compound 71 1548397-10-9 C7H8ClN3O3S
Ticagrelor Related Compound 76 Ticagrelor Related Compound 76
Vonoprazan Impurity 25 Vonoprazan Impurity 25
1-(3,4-Dimethoxyphenyl)-2-(methylsulfonyl)ethan-1-amine 1-(3,4-Dimethoxyphenyl)-2-(methylsulfonyl)ethan-1-amine 1255909-25-1 C11H17NO4S
Adefovir Impurity C Adefovir Impurity C
Blonanserin Impurity M Blonanserin Impurity M
Brexpiprazole Impurity H Brexpiprazole Impurity H
Cefaclor EP Impurity H Cefaclor EP Impurity H
Flupentixol Impurity B Flupentixol Impurity B
Ipratropium Bromide Impurity J Ipratropium Bromide Impurity J C20H29Br2NO3
Taladafil impurity Taladafil impurity 1356345-67-9 C23H23N3O4
Mirabegron 2-Oxo Impurity Mirabegron 2-Oxo Impurity 1684453-05-1 C21H22N4O3S
Riluzole 4-Bromo Impurity Riluzole 4-Bromo Impurity 144631-82-3 C8H4BrF3N2OS
Furosemide Impurity 8 Furosemide Impurity 8 41332-59-6 C7H4Cl2O5S
Irinotecan Impurity 29 Irinotecan Impurity 29 797762-11-9 C22H24N2O4
Empagliflozin Impurity 41 Empagliflozin Impurity 41
Empagliflozin Impurity 47 Empagliflozin Impurity 47
Irbesartan Irbesartan 141745-36-0 C23H26N6O
SULPIRIDE IMPURITY A SULPIRIDE IMPURITY A
(2Z)-2,3-Dehydroxy Atorvastatin (>90% Z) (2Z)-2,3-Dehydroxy Atorvastatin (>90% Z) 1191901-60-6 C33H33FN2O4
(6α,11β)-11,21-Dihydroxy-6-methyl-pregna-1,4-diene-3,20-dione (6α,11β)-11,21-Dihydroxy-6-methyl-pregna-1,4-diene-3,20-dione 103744-18-9 C22H30O4
2,5-Thiazolylmethyl Diacarbonate 2,5-Thiazolylmethyl Diacarbonate 144142-33-6 C28H30N4O5S2
4-(2-Chloroethyl)-N-methoxy-N,α,α-trimethyl-benzeneacetamide 4-(2-Chloroethyl)-N-methoxy-N,α,α-trimethyl-benzeneacetamide 1638785-17-7 C14H20ClNO2
Cefuroxime Impurity A Double-Bond Shift Impurity Cefuroxime Impurity A Double-Bond Shift Impurity
4-(difluoromethoxy)-N1-((3,4-dimethoxypyridin-2-yl)methyl)benzene-1,2-diamine 4-(difluoromethoxy)-N1-((3,4-dimethoxypyridin-2-yl)methyl)benzene-1,2-diamine 2641896-99-1 C15H17F2N3O3
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