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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
Isavuconazole Impurity 39 Isavuconazole Impurity 39 207224-73-5 C21H18F2N4OS
Anastrozole Impurity 41 Anastrozole Impurity 41
Anastrozole Impurity 41 Anastrozole Impurity 41
Isavuconazole Impurityi45 Isavuconazole Impurityi45
Gatifloxacinacid Gatifloxacinacid 121577-32-0 C19H22FN3O4.ClH
Bisoprolol Impurity 41 Bisoprolol Impurity 41
1,4-Naphthalenedione, 2-(3-hydroxy-3,7,11,15-tetramethyl-1,6,10,14-hexadecatetraenyl)-3-methyl-, (,E,E)- (9CI) 1,4-Naphthalenedione, 2-(3-hydroxy-3,7,11,15-tetramethyl-1,6,10,14-hexadecatetraenyl)-3-methyl-, (,E,E)- (9CI) 65061-22-5 C31H40O3
Piperacilin Piperacilin
	Varenicline Impurity D Varenicline Impurity D 1002359-81-0
2-Propanone, 1-(2-hydroxypropoxy)- (9CI) 2-Propanone, 1-(2-hydroxypropoxy)- (9CI) 90817-38-2 C6H12O3
Nirmatrelvir Impurity 4 Nirmatrelvir Impurity 4
Nifedipine Impurity L Nifedipine Impurity L
2-Pyrrolidinone, 3,4-dihydroxy-5-(hydroxymethyl)-, (3R,4R,5R)- (9CI) 2-Pyrrolidinone, 3,4-dihydroxy-5-(hydroxymethyl)-, (3R,4R,5R)- (9CI) 155102-96-8 C5H9NO4
Bumetanide Impurity 24 Bumetanide Impurity 24
Rocuronium Bromide Impurity 37、38、39 Rocuronium Bromide Impurity 37、38、39
Ritonavir EP Impurity HIJ Ritonavir EP Impurity HIJ
Crisaborole Impurity 42 Crisaborole Impurity 42
2,3-DICHLOROPYRIDINE-5-CARBONYL CHLORIDE 2,3-DICHLOROPYRIDINE-5-CARBONYL CHLORIDE 54127-29-6 C6H2Cl3NO
Ganciclovir EP Impurity Ganciclovir EP Impurity
Crisaborole Impurity 15 Crisaborole Impurity 15
Latamoxef impurity A Latamoxef impurity A
5,8-Dihydroxy-1,4-bis-[2-(2-hydroxy-ethylamino)-ethylamino]-2,3-dihydro-anthraquinone 5,8-Dihydroxy-1,4-bis-[2-(2-hydroxy-ethylamino)-ethylamino]-2,3-dihydro-anthraquinone 70476-74-3 C22H30N4O6
(E)-methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate (E)-methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate
4-Acetyl-2-fluorobiphenyl 4-Acetyl-2-fluorobiphenyl 42771-79-9 C14H11FO
m-xylene-4,alpha,alpha'-triol m-xylene-4,alpha,alpha'-triol 2937-60-2 C8H10O3
Oseltamivir Impurity 107 Oseltamivir Impurity 107
Oseltamivir  Impurity 66 Oseltamivir Impurity 66
Benzonitrile, 2-[(3,4-dihydro-6-methoxy-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl)methyl]- Benzonitrile, 2-[(3,4-dihydro-6-methoxy-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl)methyl]- 2514763-78-9 C14H13N3O3
Benzonitrile, 2-[(3,4-dihydro-6-methoxy-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl)methyl]- Benzonitrile, 2-[(3,4-dihydro-6-methoxy-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl)methyl]- 2514763-78-9 C14H13N3O3
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[(1E)-2-(4-methyl-5-thiazolyl)ethenyl]-8-oxo-7-[(2-phenylacetyl)amino]-, (4-methoxyphenyl)methyl ester, (6R,7R)- 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[(1E)-2-(4-methyl-5-thiazolyl)ethenyl]-8-oxo-7-[(2-phenylacetyl)amino]-, (4-methoxyphenyl)methyl ester, (6R,7R)- 104146-11-4 C29H27N3O5S2
Dapagliflozin Impurity 46 Dapagliflozin Impurity 46
Troxipide Impurity 6 Troxipide Impurity 6
Piperacillin Impurity K Piperacillin Impurity K
2-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzoic acid 2-(6'-oxo-1'-phenyl-1',6'-dihydro-[2,3'-bipyridin]-5'-yl)benzoic acid
3-Thiophenecarboxylic acid, 4-methyl-5-(4-nitrophenyl)-2-[(propoxycarbonyl)amino]-, ethyl ester 3-Thiophenecarboxylic acid, 4-methyl-5-(4-nitrophenyl)-2-[(propoxycarbonyl)amino]-, ethyl ester 2591260-03-4 C18H20N2O6S
1H-Benzimidazol-2-amine, 5,6-dichloro-N-(1-methylethyl)-1-(2,3,5-tri-O-acetyl-β-L-ribofuranosyl)- 1H-Benzimidazol-2-amine, 5,6-dichloro-N-(1-methylethyl)-1-(2,3,5-tri-O-acetyl-β-L-ribofuranosyl)- 176161-56-1 C21H25Cl2N3O7
Pemetrexed disodium Impurity 32 Pemetrexed disodium Impurity 32
Androsta-1,4-diene-17-carboxylic acid, 11,16,17-trihydroxy-3-oxo-, (11β,16α,17α)- Androsta-1,4-diene-17-carboxylic acid, 11,16,17-trihydroxy-3-oxo-, (11β,16α,17α)- 1185143-75-2 C20H26O6
(3R,5R)-7-(1-((3R,5R)-6-carboxy-3,5-dihydroxyhexyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrole-3-carboxamido)-3,5-dihydroxyheptanoic acid (3R,5R)-7-(1-((3R,5R)-6-carboxy-3,5-dihydroxyhexyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrole-3-carboxamido)-3,5-dihydroxyheptanoic acid
Tazobactam Impurity LTE Tazobactam Impurity LTE
Isavuconazole Impurity 47 Isavuconazole Impurity 47
5,5'-((1R,1'R)-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)azanediyl)bis(1-hydroxyethane-2,1-diyl))bis(8-(benzyloxy)quinolin-2(1H)-one) 5,5'-((1R,1'R)-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)azanediyl)bis(1-hydroxyethane-2,1-diyl))bis(8-(benzyloxy)quinolin-2(1H)-one) 753498-27-0 C49H49N3O6
2-((6S,8S,9S,10R,11S,13S,14S,17S)-11-hydroxy-6,10,13-trimethyl-3-oxo- 6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)-2-oxoacetic acid 2-((6S,8S,9S,10R,11S,13S,14S,17S)-11-hydroxy-6,10,13-trimethyl-3-oxo- 6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl)-2-oxoacetic acid
	Eltrombopag Impurity 37 Eltrombopag Impurity 37 350024-70-3 C14H18N2O
(S)-N-(2-(1-(3-ethoxy-4-methoxyphenyl)-2-((2-hydroxyethyl)sulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide (S)-N-(2-(1-(3-ethoxy-4-methoxyphenyl)-2-((2-hydroxyethyl)sulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide C23H26N2O8S
2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropan-1-ol 2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropan-1-ol C28H39N3O2
Tafluprost Impurity 20 Tafluprost Impurity 20
Rosuvastatin Impurity 149 Rosuvastatin Impurity 149
2-CHLOROMETHYL-5-TRIFLUOROMETHYL-[1,3,4]OXADIAZOLE 2-CHLOROMETHYL-5-TRIFLUOROMETHYL-[1,3,4]OXADIAZOLE 723286-98-4 C4H2ClF3N2O
Rifampicin Quinone Oxide Rifampicin Quinone Oxide
1-(2-(4-(((2-(4-(([1,1'-biphenyl]-2-ylcarbamoyl)oxy)piperidin-1-yl)ethyl)(methyl)amino)methyl)-N-methylbenzamido)ethyl)piperidin-4-yl [1,1'-biphenyl]-2-ylcarbamate 1-(2-(4-(((2-(4-(([1,1'-biphenyl]-2-ylcarbamoyl)oxy)piperidin-1-yl)ethyl)(methyl)amino)methyl)-N-methylbenzamido)ethyl)piperidin-4-yl [1,1'-biphenyl]-2-ylcarbamate
1-Phenyl-3,4-dihydroisoquinoline 1-Phenyl-3,4-dihydroisoquinoline 52250-50-7 C15H13N
Pyrazinecarboxamide, 3,6-difluoro- (9CI) Pyrazinecarboxamide, 3,6-difluoro- (9CI) 356783-29-4 C5H3F2N3O
Benzamide, 3-hydrazino- (9CI) Benzamide, 3-hydrazino- (9CI) 473927-51-4 C7H9N3O
Brexpiprazole Impurity ABCDEFGHJKL Brexpiprazole Impurity ABCDEFGHJKL
Acetamide, N-[4-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]- Acetamide, N-[4-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]- 871701-23-4 C26H23FIN5O4
p,p'-(2-pyridylmethylene)bisphenol p,p'-(2-pyridylmethylene)bisphenol 603-41-8 C18H15NO2
Tazobactam Impurity DBT Tazobactam Impurity DBT
diginatin diginatin 52589-12-5 C41H64O15
Thiophene, 2-(2-fluorophenyl)-5-[(5-iodo-2-methylphenyl)methyl]- Thiophene, 2-(2-fluorophenyl)-5-[(5-iodo-2-methylphenyl)methyl]- 2436275-33-9 C18H14FIS
3-Chloro Avanafil 3-Chloro Avanafil
Revefenacin Impurity 2 Revefenacin Impurity 2 1158699-78-5 C14H17NO4
(R)-2-(4-Methoxyphenyl)-1-methylethanamine (R)-2-(4-Methoxyphenyl)-1-methylethanamine 58993-79-6 C10H15NO
N-[5-[(1RS)-2-[benzyl[(1RS)-2-(4-methoxyphenyl)- 1-methylethyl]amino]-1-hydroxyethyl]-2- hydroxyphenyl]formamide N-[5-[(1RS)-2-[benzyl[(1RS)-2-(4-methoxyphenyl)- 1-methylethyl]amino]-1-hydroxyethyl]-2- hydroxyphenyl]formamide 2514947-17-0 C26H30N2O4
Azelastine Impurity K Azelastine Impurity K
(4R,6R)-6-(2-((1S,2S)-2,6-dimethyl-1,2,3,4-tetrahydronaphthalen-1- (4R,6R)-6-(2-((1S,2S)-2,6-dimethyl-1,2,3,4-tetrahydronaphthalen-1-
Carbazochrome Sodium Sulfonate Impurity 1 Carbazochrome Sodium Sulfonate Impurity 1
Rosuvastatin Impurity 147 Rosuvastatin Impurity 147
Febuxostat Impurity 15 Complete Set Febuxostat Impurity 15 Complete Set
Cetrorelix Impurity 10 Cetrorelix Impurity 10
Cetrorelix Impurity 3 (9-D-Pro) Cetrorelix Impurity 3 (9-D-Pro)
Peramivir Intermediate Impurity 42 Peramivir Intermediate Impurity 42
Nintedanib impurity A drops Nintedanib impurity A drops
Tofacitinib impurity N drops Tofacitinib impurity N drops
Carboprost impurity 999 Carboprost impurity 999
Bumetanide impurity C drops Bumetanide impurity C drops
Apixaban Impurity 79 Apixaban Impurity 79
17alpha-Hydroxytrenbolone 17alpha-Hydroxytrenbolone 80657-17-6 C18H22O2
Oseltamivir Impurity 125 Oseltamivir Impurity 125
diltiazem hydrochloride diltiazem hydrochloride 103532-27-0 C22H27ClN2O4S
(R)-Terazosin (R)-Terazosin 109351-34-0 C19H25N5O4
CHLOROAURIC ACID HYDRATE CHLOROAURIC ACID HYDRATE 27988-77-8 AuCl4H3O
Methyl (1S,4R)-4-Amino-2-Cyclopentene-1-Carboxylate Methyl (1S,4R)-4-Amino-2-Cyclopentene-1-Carboxylate 138923-03-2 C7H11NO2
L-Alanine,propylester(9CI) L-Alanine,propylester(9CI) 58989-06-3 C6H13NO2
Oprinone Impurity 4 Oprinone Impurity 4
Methanone, [(2S)-2-(6-chloro-7-methyl-1H-benzimidazol-2-yl)-2-methyl-1-pyrrolidinyl][5-hydroxy-2-(2H-1,2,3-triazol-2-yl)phenyl]- Methanone, [(2S)-2-(6-chloro-7-methyl-1H-benzimidazol-2-yl)-2-methyl-1-pyrrolidinyl][5-hydroxy-2-(2H-1,2,3-triazol-2-yl)phenyl]- 2901043-05-6 C22H21ClN6O2
6-(1-Cyclopropyl-1H-pyrazol-4-yl)-3-[difluoro(6-fluoro-2H-indazol-5-yl)methyl]-1,2,4-triazolo[4,3-b]pyridazine 6-(1-Cyclopropyl-1H-pyrazol-4-yl)-3-[difluoro(6-fluoro-2H-indazol-5-yl)methyl]-1,2,4-triazolo[4,3-b]pyridazine 1440964-95-3 C19H13F3N8
Mizolastine impurity C Mizolastine impurity C
N-hydroxyphenetidine N-hydroxyphenetidine 38246-95-6
bergaptol-O-glucopyranoside bergaptol-O-glucopyranoside 131623-13-7 C17H16O9
Rosuvastatin Impurity 172 Rosuvastatin Impurity 172
pefloxacin N-oxide pefloxacin N-oxide 85145-21-7 C17H20FN3O4
2,3-dimethyl-1,4-naphthoquinone 2,3-dimethyl-1,4-naphthoquinone 2197-57-1 C12H10O2
Nemonoxacin Impurity 8 Nemonoxacin Impurity 8 2770004-82-3 C24H29N3O8
SALVIAMILTIORRHIZA SALVIAMILTIORRHIZA
(1-ETHYL-3-PIPERIDINYL)METHYLAMINE (1-ETHYL-3-PIPERIDINYL)METHYLAMINE 102459-02-9 C8H18N2
(1S,2R)-2-(((2,4-dimethylpyrimidin-5-yl)oxy)methyl)-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl)cyclopropanecarboxamide (1S,2R)-2-(((2,4-dimethylpyrimidin-5-yl)oxy)methyl)-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl)cyclopropanecarboxamide
Lemborexant impurity 14 Lemborexant impurity 14
8-HYDROXY MIRTAZAPINE 8-HYDROXY MIRTAZAPINE 102335-57-9 C17H19N3O
1-[2-Amino-1-(4-benzyloxyphenyl)-ethyl]-cyclohexanol 1-[2-Amino-1-(4-benzyloxyphenyl)-ethyl]-cyclohexanol 93413-61-7 C23H31NO2
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