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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
Benzonitrile, 4-[3-[(acetyloxy)methyl]-4-bromophenoxy]- Benzonitrile, 4-[3-[(acetyloxy)methyl]-4-bromophenoxy]- 2227126-09-0 C16H12BrNO3
3-Pyridineacrylonitrile, α-(m-chlorophenyl)-β-hydroxy- (8CI) 3-Pyridineacrylonitrile, α-(m-chlorophenyl)-β-hydroxy- (8CI) 18206-80-9 C14H9ClN2O
Pharmacopoeia experiment Pharmacopoeia experiment
Androsta-3,16-dien-17-ol, acetate, (5α)- (9CI) Androsta-3,16-dien-17-ol, acetate, (5α)- (9CI) 103088-58-0 C21H30O2
1-Naphthalenamine, 1,2,3,4-tetrahydro-N-methyl-4-phenyl-, (1S,4S)- 1-Naphthalenamine, 1,2,3,4-tetrahydro-N-methyl-4-phenyl-, (1S,4S)- 91797-61-4 C17H19N
2-Pyridineethanamine, N-methyl-N-nitroso- 2-Pyridineethanamine, N-methyl-N-nitroso- 32635-81-7 C8H11N3O
Peramivir Impurity 45 Peramivir Impurity 45
Pentanamide, 5-(diphenylphosphinyl)-N-ethyl- Pentanamide, 5-(diphenylphosphinyl)-N-ethyl- 2512198-63-7 C19H24NO2P
1H-Pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline-8(7H)-carboxylic acid, 2,3,6b,9,10,10a-hexahydro-, ethyl ester, (6bR,10aS)- 1H-Pyrido[3',4':4,5]pyrrolo[1,2,3-de]quinoxaline-8(7H)-carboxylic acid, 2,3,6b,9,10,10a-hexahydro-, ethyl ester, (6bR,10aS)- 313369-17-4 C16H21N3O2
Ergoline-8-methanol, 10-hydroxy-1,6-dimethyl-, 8-(5-bromo-3-pyridinecarboxylate), (8β)- Ergoline-8-methanol, 10-hydroxy-1,6-dimethyl-, 8-(5-bromo-3-pyridinecarboxylate), (8β)- 57935-66-7 C23H24BrN3O3
(5S,6S,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-carboxylic acid 5-oxide (5S,6S,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-carboxylic acid 5-oxide
Ethanone, 2-chloro-1-[3-nitro-4-(phenylmethoxy)phenyl]- Ethanone, 2-chloro-1-[3-nitro-4-(phenylmethoxy)phenyl]- 871266-45-4 C15H12ClNO4
Benzeneethanamine, N-[2-(3,4-dimethoxyphenyl)ethyl]-3,4-dimethoxy- Benzeneethanamine, N-[2-(3,4-dimethoxyphenyl)ethyl]-3,4-dimethoxy- 24997-88-4 C20H27NO4
1H-Pyrazolo[3,4-c]pyridine-3-carboxamide, 4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-6-(4-nitrophenyl)-7-oxo- 1H-Pyrazolo[3,4-c]pyridine-3-carboxamide, 4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-6-(4-nitrophenyl)-7-oxo- 1642569-42-3 C20H17N5O5
1H-Pyrazolo[3,4-c]pyridine-3-carboxamide, 4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-6-(4-nitrophenyl)-7-oxo- 1H-Pyrazolo[3,4-c]pyridine-3-carboxamide, 4,5,6,7-tetrahydro-1-(4-methoxyphenyl)-6-(4-nitrophenyl)-7-oxo- 1642569-42-3 C20H17N5O5
METHYL 2-[(2,5-DICHLOROBENZOYL)AMINO]ACETATE METHYL 2-[(2,5-DICHLOROBENZOYL)AMINO]ACETATE 338965-44-9 C10H9Cl2NO3
4-(DIPHENYLMETHYL)-1-PIPERAZINEETHANOL DIHYDROCHLORIDE 4-(DIPHENYLMETHYL)-1-PIPERAZINEETHANOL DIHYDROCHLORIDE 108983-83-1 C19H26Cl2N2O
2-chloro-1-(5-isopropoxy-5H-chromeno[2,3-b]pyridin-7-yl)propan-1-one 2-chloro-1-(5-isopropoxy-5H-chromeno[2,3-b]pyridin-7-yl)propan-1-one
Cinacalcet Impurity 38 HCl Cinacalcet Impurity 38 HCl 938177-81-2 C21H24ClN
Norepinephrine Impurity 23 Norepinephrine Impurity 23 1528622-09-4 C9H13NO3
Brexpiprazole Impurity 77 Brexpiprazole Impurity 77 1783311-11-4 C12H14N2S
(S)-1-(isopropylamino)-3-(4-(2-methoxyethyl)phenoxy)propan-2-ol (S)-1-(isopropylamino)-3-(4-(2-methoxyethyl)phenoxy)propan-2-ol 114218-35-8 C15H26ClNO3
Dapagliflozin Impurity (MW:423Da) Dapagliflozin Impurity (MW:423Da)
Ramipril - Isomer Impurity 1 Ramipril - Isomer Impurity 1
Aripiprazole peroxide degradation Impurity (MW:480Da) Aripiprazole peroxide degradation Impurity (MW:480Da)
Fosinopril Sodium Impurity A (Fosinoprilat) Fosinopril Sodium Impurity A (Fosinoprilat)
Dapoxetine Impurity 40 Dapoxetine Impurity 40
Doxofylline Impurity 15 Doxofylline Impurity 15
Iohexol Impurity 10 Iohexol Impurity 10
Salbutamol Impurity 40 Salbutamol Impurity 40
Benzylpenicillin EP(CP) Impurity F Benzylpenicillin EP(CP) Impurity F
(3R,5R)-7-(2-(2-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid (3R,5R)-7-(2-(2-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoic acid 2243639-98-5 C33H37CaFN2O5
Flucloxacillin sodium EP Impurity A Flucloxacillin sodium EP Impurity A
Nilotinib Impurity 28 Nilotinib Impurity 28 1807607-72-2 C28H20F3N7O3
(7R,8R)-Dihydrodehydrodiconiferyl alcohol 9-O-β-D-glucoside (7R,8R)-Dihydrodehydrodiconiferyl alcohol 9-O-β-D-glucoside 351346-10-6 C26H34O11
(6R,9S)-3-Oxo-α-ionol glucoside (6R,9S)-3-Oxo-α-ionol glucoside 159813-37-3 C19H30O7
T-IRR T-IRR
Escitalopram Acid Impurity Escitalopram Acid Impurity 1133881-04-5 C20H22FNO3
1,3,6,10,14-Hexadecapentaene, 3,7,11,15-tetramethyl-, (3E,6E,10E)- 1,3,6,10,14-Hexadecapentaene, 3,7,11,15-tetramethyl-, (3E,6E,10E)- 77898-97-6 C20H32
BROMOCRIPTINE IMPURITY A BROMOCRIPTINE IMPURITY A C32H40BrN5O5
Atorvastatin Impurity E Intermediate Atorvastatin Impurity E Intermediate
Ceftazidime Double Mother Nucleus Impurity Ceftazidime Double Mother Nucleus Impurity
Cefuroxime Sodium Trans Impurity I,(E)-Cefuroxime Sodium Impurity I Cefuroxime Sodium Trans Impurity I,(E)-Cefuroxime Sodium Impurity I
Faropenem Degradation Impurity B Faropenem Degradation Impurity B
Oxacillin Impurity 1 Oxacillin Impurity 1 36231-30-8 C19H19N3O6S
Brivaracetam Impurity 33 Brivaracetam Impurity 33
Arformoterol Impurity 24 Arformoterol Impurity 24 477552-93-5 C19H24N2O3
Pregabalin Impurity 99 Pregabalin Impurity 99 949890-75-9 C16H23NO4
Roxatidine Impurity 9 Roxatidine Impurity 9 87327-60-4 C4H6O4
Regofenib impurity K Regofenib impurity K
Chlorpheniramine Impurity 4 Chlorpheniramine Impurity 4
Peramivir Impurity 43 Peramivir Impurity 43
N-(4-BROMOBUTYL)-7-(4-BROMOBUTOXY)-QUINOLINE-2(1H)-ONE N-(4-BROMOBUTYL)-7-(4-BROMOBUTOXY)-QUINOLINE-2(1H)-ONE 1076199-56-8 C17H21Br2NO2
7-methoxy-3,4-dihydro-1-naphthalenylacetonitrile 7-methoxy-3,4-dihydro-1-naphthalenylacetonitrile 861960-34-1 C13H13NO
sodium:(2S)-2-[12-ethyl-8-(hydroxymethyl)-9-oxo-2-(4-piperidin-1-ylpiperidine-1-carbonyl)oxy-11H-indolizino[1,2-b]quinolin-7-yl]-2-hydroxybutanoate sodium:(2S)-2-[12-ethyl-8-(hydroxymethyl)-9-oxo-2-(4-piperidin-1-ylpiperidine-1-carbonyl)oxy-11H-indolizino[1,2-b]quinolin-7-yl]-2-hydroxybutanoate 1329502-92-2 C33H41N4NaO7
QFJAHHNMKTWTGZ-DZAPPIOQSA-N QFJAHHNMKTWTGZ-DZAPPIOQSA-N 2045402-27-3 C35H36ClNO4S
N-(3R)-1-Azabicyclo[2.2.2]oct-3-yl-5,6,7,8-tetrahydro-1-naphthalenecarboxamide N-(3R)-1-Azabicyclo[2.2.2]oct-3-yl-5,6,7,8-tetrahydro-1-naphthalenecarboxamide 1374226-74-0 C18H24N2O
BJQMFFOQQWEWAF-DGBYXFBUSA-N BJQMFFOQQWEWAF-DGBYXFBUSA-N 1709825-83-1 C31H41ClO8
4-amino-5-ethylsulfonyl-2-methoxy-N-[[1-(1,1,2,2,2-pentadeuterioethyl)pyrrolidin-2-yl]methyl]benzamide 4-amino-5-ethylsulfonyl-2-methoxy-N-[[1-(1,1,2,2,2-pentadeuterioethyl)pyrrolidin-2-yl]methyl]benzamide 1216626-17-3 C17H22D5N3O4S
3-Oxo Atorvastatin tert-Butyl Ester 3-Oxo Atorvastatin tert-Butyl Ester 134394-98-2 C37H41FN2O5
(1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(4-fluorophenyl)cyclopropyl)amino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol (1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(4-fluorophenyl)cyclopropyl)amino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol C23H29FN6O4S
(5-Ethyl-1H-imidazol-4-yl)methanol (5-Ethyl-1H-imidazol-4-yl)methanol 38603-74-6 C6H10N2O
(Z)-1-(6-methylpyridin-3-yl)-2-(4-(methylsulfonyl)phenyl)ethanone oxime (Z)-1-(6-methylpyridin-3-yl)-2-(4-(methylsulfonyl)phenyl)ethanone oxime 1810761-43-3 C15H16N2O3S
tert-butyl 2-((4R,6S)-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate tert-butyl 2-((4R,6S)-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate C14H27NO4
Apixaban Impurity A Apixaban Impurity A
ethylidene phthalide ethylidene phthalide 61658-90-0 C10H8O2
6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl) -7-methyl-7,9-dihydro-8H-purin-8-one 6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl) -7-methyl-7,9-dihydro-8H-purin-8-one 1361569-18-7 C19H15FN8O
5-(TRIFLUOROMETHYL)-3-P-TOLYL-1H-PYRAZOLE 5-(TRIFLUOROMETHYL)-3-P-TOLYL-1H-PYRAZOLE 219986-64-8 C11H9F3N2
Lucidin 3-O-glucoside Lucidin 3-O-glucoside 22255-29-4 C21H20O10
Bendamustine Impurity 26 Bendamustine Impurity 26
Canagliflozin Impurity 26 Canagliflozin Impurity 26
Edoxaban Impurity 37 Edoxaban Impurity 37 2081883-50-1 C14H27N3O3
Imatinib Impurity 10 Imatinib Impurity 10
Levofloxacin Impurity 19 Levofloxacin Impurity 19 C18H20FN3O4
Olanzapine Impurity K Olanzapine Impurity K C17H20N4S
Ticagrelor Related Compound 55 Ticagrelor Related Compound 55
Ticagrelor Related Compound 73 Ticagrelor Related Compound 73
Vildagliptin Impurity 10 Vildagliptin Impurity 10
Cefaclor Impurity 2 Cefaclor Impurity 2 722547-49-1 C17H18N2O3
Cefodizime Impurity F Cefodizime Impurity F
Olaparib Impurity F Olaparib Impurity F
Ornidazole Impurity G Ornidazole Impurity G
Recombinant Endo Beta-N-Acetylglucosaminidase (ENGASE) Recombinant Endo Beta-N-Acetylglucosaminidase (ENGASE)
1-Pentanone, 1-(2-hydroxy-5-methylphenyl)- 1-Pentanone, 1-(2-hydroxy-5-methylphenyl)- 150033-77-5 C12H16O2
3-methyl-2-pentylphenol 3-methyl-2-pentylphenol 1823068-39-8 C12H18O
PLSQ-001 TM4-QJ PLSQ-001 TM4-QJ 1227162-74-4 C18H24N2O2
(2S)-2-(2,5-dioxo-3-propylpyrrolidin-1-yl)butanoic acid (2S)-2-(2,5-dioxo-3-propylpyrrolidin-1-yl)butanoic acid 2101641-92-1 C11H17NO4
2-Pyridineethanamine, N-methyl-N-[2-(2-pyridinyl)ethyl]-, hydrochloride (1:3) 2-Pyridineethanamine, N-methyl-N-[2-(2-pyridinyl)ethyl]-, hydrochloride (1:3) 2095467-43-7 C15H20ClN3
(S)-tert-butyl (1-(3-(2-cyanobenzyl) (S)-tert-butyl (1-(3-(2-cyanobenzyl) 1618644-31-7 C23H29N5O4
(S)-tert-butyl (1-(3-(2-cyanobenzyl) (S)-tert-butyl (1-(3-(2-cyanobenzyl) 1618644-31-7 C23H29N5O4
Droxidopa Impurity 4 Droxidopa Impurity 4 55382-14-4 C31H29NO7
RV Salmonella enrichment broth (Pharmacopoeia 2015 edition) RV Salmonella enrichment broth (Pharmacopoeia 2015 edition)
(1r,4r)-4-(5,6-dibromo-2-methylquinazolin-3(4H)-yl)cyclohexan-1-ol (1r,4r)-4-(5,6-dibromo-2-methylquinazolin-3(4H)-yl)cyclohexan-1-ol
LORATADINE IMPURITY F LORATADINE IMPURITY F C22H23ClN2O2
ZIDOVUDINE IMPURITY A ZIDOVUDINE IMPURITY A
Propanoic acid, 2-[[(Z)-[1-(2-amino-4-thiazolyl)-2-[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]amino]-2-oxoethylidene]amino]oxy]-2-methyl-, 1-(1,1-dimethylethyl) ester Propanoic acid, 2-[[(Z)-[1-(2-amino-4-thiazolyl)-2-[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]amino]-2-oxoethylidene]amino]oxy]-2-methyl-, 1-(1,1-dimethylethyl) ester 330944-50-8 C17H25N5O8S2
Apixaban Impurity 16 Apixaban Impurity 16 2203740-09-2 C26H29N5O5
Canagliflozin Peroxide Impurity Canagliflozin Peroxide Impurity 2247196-28-5 C24H25FO7S
(αR)-α-Methyl-N-[3-[3-(trifluoromethyl)phenyl]propyl]-2-naphthalenemethanamine Hydrochloride (αR)-α-Methyl-N-[3-[3-(trifluoromethyl)phenyl]propyl]-2-naphthalenemethanamine Hydrochloride 2200269-28-7 C22H23ClF3N
2-(4-Fluorophenyl)-δ-hydroxy-5-(1-methylethyl)-β-oxo-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic Acid 1,1-Dimethylethyl Ester 2-(4-Fluorophenyl)-δ-hydroxy-5-(1-methylethyl)-β-oxo-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic Acid 1,1-Dimethylethyl Ester 947262-20-6 C37H41FN2O5
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