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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
PeraMpanel PeraMpanel 380918-54-7 C23H15N3O
Empagliflozin Impurity 79 Empagliflozin Impurity 79
Empagliflozin Impurity 89 Empagliflozin Impurity 89 2452301-32-3 C23H25ClO7
Levocarnitine Impurity F Levocarnitine Impurity F 6490-19-3 C7H17ClN2O2
4,4-dimethyl-2-(2-phenylpropan-2-yl)oxazo‐ line 4,4-dimethyl-2-(2-phenylpropan-2-yl)oxazo‐ line 874895-87-1 C14H19NO
Formoterol Impurity 4 Formoterol Impurity 4
3β,7β,19-Trihydroxy-25-methoxycucurbita-5,23-diene 7-O-glucoside 3β,7β,19-Trihydroxy-25-methoxycucurbita-5,23-diene 7-O-glucoside 81910-37-4 C37H62O9
Roxadustat-001 Roxadustat-001 319-57-3 C8H5BF4N2O2
Ornidazole Impurity 24 Ornidazole Impurity 24
Olanzapine impurity ANB Olanzapine impurity ANB
Pitavastatin Impurity 75 Pitavastatin Impurity 75
Febuxostat Impurity 100 Febuxostat Impurity 100
Febuxostat Impurity 101 Febuxostat Impurity 101
Febuxostat Impurity 105 Febuxostat Impurity 105
(S)-10-amino-9-fluoro-3-methyl-7-oxo-3,7-dihydro-2H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid (S)-10-amino-9-fluoro-3-methyl-7-oxo-3,7-dihydro-2H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid
Ticagrelor Impurity 129 Ticagrelor Impurity 129 1381841-36-6 C15H19NO3
Benzoic acid, 2-hydroxy-3-(2-phenyldiazenyl)- Benzoic acid, 2-hydroxy-3-(2-phenyldiazenyl)- 136819-59-5 C13H10N2O3
5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-, 5-oxide, (6R,7R)- (9CI) 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-, 5-oxide, (6R,7R)- (9CI) 97466-28-9 C18H18N8O8S3
7-(2-methoxypropanoyl)-5H-chromeno[2,3-b]pyridin-5-one 7-(2-methoxypropanoyl)-5H-chromeno[2,3-b]pyridin-5-one
Ibrutinib Impurity 42 Ibrutinib Impurity 42 2031255-24-8 C25H23N5O3
Pramipexole Impurity N Pramipexole Impurity N
Hydroxychloroquine Impurity 12 Hydrochloride Hydroxychloroquine Impurity 12 Hydrochloride 2411340-31-1 C18H26ClN3O
TIZOXANIDE GLUCURONIDE, SODIUM SALT TIZOXANIDE GLUCURONIDE, SODIUM SALT 221287-83-8 C16H14N3NaO10S
ETHYL (2E)-CHLORO(PHENYLHYDRAZONO)ACETATE ETHYL (2E)-CHLORO(PHENYLHYDRAZONO)ACETATE 28663-68-5 C10H11ClN2O2
Sugammadex sodium Impurity 50 Sugammadex sodium Impurity 50
Cabozantinib impurity 39 Cabozantinib impurity 39
Cabozantinib impurity 53 Cabozantinib impurity 53
1-(2-chloro-2-(2,4-difluorophenyl)ethyl)-1H-1,2,4-triazole 1-(2-chloro-2-(2,4-difluorophenyl)ethyl)-1H-1,2,4-triazole 206050-24-0 C10H8ClF2N3
methyl 1-phenylethanesulfonate methyl 1-phenylethanesulfonate 883835-57-2 C9H12O3S
Doxofylline Impurity 22 Doxofylline Impurity 22
Dapoxetine impurity 61 Dapoxetine impurity 61
Dapoxetine impurity 55 Dapoxetine impurity 55
1,3-Benzenediamine, 4-methyl-N3-[4-methyl-6-(3-pyridinyl)-2-pyrimidinyl]- 1,3-Benzenediamine, 4-methyl-N3-[4-methyl-6-(3-pyridinyl)-2-pyrimidinyl]- 1032314-73-0 C17H17N5
5-methoxy-1-methyl-1H-benzo[d]imidazole-2-sulfonic acid 5-methoxy-1-methyl-1H-benzo[d]imidazole-2-sulfonic acid
Teneligliptin Impurity 17 Teneligliptin Impurity 17
Ethanone, 2-bromo-1-(5-bromo-4-chloro-2-thienyl)- Ethanone, 2-bromo-1-(5-bromo-4-chloro-2-thienyl)- 1519427-10-1 C6H3Br2ClOS
1(3H)-Isobenzofuranone, 3-(1-methylpropyl)- 1(3H)-Isobenzofuranone, 3-(1-methylpropyl)- 261783-87-3 C12H14O2
(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl methyl sulfate (2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl methyl sulfate
Carbamic acid, N-[(1R)-2-[5-(2-fluoro-3-hydroxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3,6-dihydro-4-methyl-2,6-dioxo-1(2H)-pyrimidinyl]-1-phenylethyl]-, 1,1-dimethylethyl ester Carbamic acid, N-[(1R)-2-[5-(2-fluoro-3-hydroxyphenyl)-3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-3,6-dihydro-4-methyl-2,6-dioxo-1(2H)-pyrimidinyl]-1-phenylethyl]-, 1,1-dimethylethyl ester 1062642-68-5 C32H30F5N3O5
2-Oxazolidinone, 5-(2,2-dimethyl-4H-1,3-benzodioxin-6-yl)-, (5S)- 2-Oxazolidinone, 5-(2,2-dimethyl-4H-1,3-benzodioxin-6-yl)-, (5S)- 2514942-86-8 C13H15NO4
Heptanoic acid, 7-[[(3R,5R)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxy-1-oxoheptyl]amino]-3,5-dihydroxy-, 1,1-dimethylethyl ester, (3R,5R)- Heptanoic acid, 7-[[(3R,5R)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]-3,5-dihydroxy-1-oxoheptyl]amino]-3,5-dihydroxy-, 1,1-dimethylethyl ester, (3R,5R)- 2409556-65-4 C44H56FN3O8
6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-5-hydroxy-3-oxo-, (5S,6E)- 6-Heptenoic acid, 7-[4-(4-fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-5-hydroxy-3-oxo-, (5S,6E)- 1803023-43-9 C22H26FN3O6S
Drug impurity detection and analysis Drug impurity detection and analysis
1-Pyrrolidinecarboxamide, N-[5-[(2S)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl]-3-hydroxy-, (3R)- 1-Pyrrolidinecarboxamide, N-[5-[(2S)-2-(2,5-difluorophenyl)-1-pyrrolidinyl]pyrazolo[1,5-a]pyrimidin-3-yl]-3-hydroxy-, (3R)- 2409590-08-3 C21H22F2N6O2
Sertraline Impurity 20 Sertraline Impurity 20 1498236-91-1 C16H14Cl2O
Budesonide Impurity 21 Budesonide Impurity 21
2H-3-Benzazepin-2-one, 3-(3-bromopropyl)-1,3,4,5-tetrahydro-7,8-dimethoxy- 2H-3-Benzazepin-2-one, 3-(3-bromopropyl)-1,3,4,5-tetrahydro-7,8-dimethoxy- 1192174-72-3 C15H20BrNO3
Benzamide, 2-[(1-acetyl-3-iodo-1H-indazol-6-yl)thio]-N-methyl- Benzamide, 2-[(1-acetyl-3-iodo-1H-indazol-6-yl)thio]-N-methyl- 1639138-00-3 C17H14IN3O2S
2-Pyrrolidinone, 3-ethylidene- 2-Pyrrolidinone, 3-ethylidene- 27428-45-1 C6H9NO
1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-nitro-, ethyl ester, (3R,4R,5S)- 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-nitro-, ethyl ester, (3R,4R,5S)- 949164-64-1 C16H26N2O6
Peramivir Impurity 55 Peramivir Impurity 55
Peramivir Impurity 60 Peramivir Impurity 60
Hexanoic acid, 3-(hydroxymethyl)-, methyl ester, (3R)- Hexanoic acid, 3-(hydroxymethyl)-, methyl ester, (3R)- 2408196-94-9 C8H16O3
Loratadine EP Impurity L Loratadine EP Impurity L
Metronidazole Impurity 2 Metronidazole Impurity 2
ethyl 2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5-
carboxylate ethyl 2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5- carboxylate 144060-84-4 C17H18N2O3S
Dasatinib Impurity 24 Dasatinib Impurity 24
Pregabalin Impurity 19 Pregabalin Impurity 19 89015-27-0 C11H14O3
Quercetin 3-O-(6''-galloyl)-β-D-glucopyranoside Quercetin 3-O-(6''-galloyl)-β-D-glucopyranoside 56316-75-7 C28H24O16
4-Desmethyl 3-Methyl Vortioxetine Hydrochloride 4-Desmethyl 3-Methyl Vortioxetine Hydrochloride 1293343-01-7
OFLOXACIN N-OXIDE (MIXTURE OF DIASTEREOMERS) OFLOXACIN N-OXIDE (MIXTURE OF DIASTEREOMERS) 104721-52-0 C18H20FN3O5
4-[[2-(2-Amino-4-thiazolyl)acetyl]amino]-benzeneacetic Acid 4-[[2-(2-Amino-4-thiazolyl)acetyl]amino]-benzeneacetic Acid 1365244-64-9 C13H13N3O3S
PEONIN CHLORIDE(SH) PEONIN CHLORIDE(SH) 132-37-6 C28H33ClO16
OCTAKIS-6-BROMO-6-DEOXY-GAMMA-CYCLODEXTRIN OCTAKIS-6-BROMO-6-DEOXY-GAMMA-CYCLODEXTRIN 53784-84-2 C48H72Br8O32
2-Ethynylaniline 2-Ethynylaniline 52670-38-9 C8H7N
Recombinant N-Acetyl Alpha-D-Glucosaminidase (NAGLU) Recombinant N-Acetyl Alpha-D-Glucosaminidase (NAGLU)
(2R,3R,4R,5R)-2-(4-amino-2-oxo (2R,3R,4R,5R)-2-(4-amino-2-oxo 1415316-72-1 C12H16N4O7
(R)-2-(3-(diisopropylamino)-1-phenylpropyl)phenol (R)-2-(3-(diisopropylamino)-1-phenylpropyl)phenol C21H29NO
Dexamethasone EP impurities F Dexamethasone EP impurities F
4-amino-1-((2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-1,3,5-triazin-2(1H)-one compound with (2R,3S,4R,5S)-2-(hydroxymethyl)-5-methyltetrahydrofuran-3,4-diol 4-amino-1-((2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)-1,3,5-triazin-2(1H)-one compound with (2R,3S,4R,5S)-2-(hydroxymethyl)-5-methyltetrahydrofuran-3,4-diol
D-Ribofuranose, 1-C-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-2,3,5-tris-O-(phenylmethyl)- D-Ribofuranose, 1-C-(4-aminopyrrolo[2,1-f][1,2,4]triazin-7-yl)-2,3,5-tris-O-(phenylmethyl)- 1355049-94-3 C32H32N4O5
Delamanid Impurity 1 Delamanid Impurity 1
N-[4-[(6,7-Dimethoxy-4-quinolinyl)oxy]phenyl]-N'-(4-fluoro-3-hydroxyphenyl)-1,1-cyclopropanedicarboxamide N-[4-[(6,7-Dimethoxy-4-quinolinyl)oxy]phenyl]-N'-(4-fluoro-3-hydroxyphenyl)-1,1-cyclopropanedicarboxamide 1628530-41-5 C28H24FN3O6
Oseltamivir Impurity Mixture (MW:486 Da) Oseltamivir Impurity Mixture (MW:486 Da)
2,2'-(7-((2R,3S)-1,3,4-trihydroxybutan-2-yl)-10-((2S,3R)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,4-diyl)diacetic acid Gd3+ 2,2'-(7-((2R,3S)-1,3,4-trihydroxybutan-2-yl)-10-((2S,3R)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,4-diyl)diacetic acid Gd3+
(R)-Ethyl 3-(bromomethyl)hexanoate (R)-Ethyl 3-(bromomethyl)hexanoate 1956435-91-8 C9H17BrO2
Flucloxacillin Sodium EP Impurity B Flucloxacillin Sodium EP Impurity B
Acyclovir Impurity 15 Acyclovir Impurity 15
Brivaracetam Impurity 5 Brivaracetam Impurity 5 1942054-60-5 C7H13BrO2
(S,E)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-5-hydroxyhept-2-enoic acid calcium(II) (S,E)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-5-hydroxyhept-2-enoic acid calcium(II) 1659317-57-3 C33H35CaFN2O4
Epalrestat Impurity 4 Epalrestat Impurity 4 130786-32-2 C8H9NO3S2
Olmesartan Impurity 58 Olmesartan Impurity 58 2190488-06-1 C12H22N2O2
Apixaban Impurity 73 Apixaban Impurity 73 1998079-13-2 C44H40N8O8
Alectinib Impurity 10 Alectinib Impurity 10 1256584-81-2 C28H29N3O3
Acemetacin Impurity C Acemetacin Impurity C
Propofol Impurity II (2,6-Diisopropyl-1,4-benzoquinone) Propofol Impurity II (2,6-Diisopropyl-1,4-benzoquinone)
Vonoprazan Impurity 58 Vonoprazan Impurity 58
Tafluprost Impurity 12 Tafluprost Impurity 12
METOPROLOL IMPURITY A METOPROLOL IMPURITY A C15H25NO3
Regorafenib Impurity MJ Regorafenib Impurity MJ
Aztreonam Open-Ring Desulfurization Impurity Aztreonam Open-Ring Desulfurization Impurity
L-Cefadroxil Oxide Impurity L-Cefadroxil Oxide Impurity
Azlocillin dioxide Impurity Azlocillin dioxide Impurity
Verteporfin impurity Verteporfin impurity 121310-58-5 C40H40N4O8
Peramivir Impurity 25 Peramivir Impurity 25
Peramivir Impurity 33 Peramivir Impurity 33 2758048-78-9 C18H34N2O5
Imatinib impurity XT Imatinib impurity XT
IOHEXOL RELATED COMPOUND C (100 MG) (N,N'- BIS(2,3-DIHYDROXYPROPYL)-5-NITRO-1,3-BENZENEDI- CARBOXAMIDE) IOHEXOL RELATED COMPOUND C (100 MG) (N,N'- BIS(2,3-DIHYDROXYPROPYL)-5-NITRO-1,3-BENZENEDI- CARBOXAMIDE)
N-(4-AMINO-6,7-DIMETHOXYQUINAZOL-2-YL)-N-METHYL-PROPYLENEDIAMINE, HYDROCHLORIDE N-(4-AMINO-6,7-DIMETHOXYQUINAZOL-2-YL)-N-METHYL-PROPYLENEDIAMINE, HYDROCHLORIDE 81403-69-2 C14H22ClN5O2
FAMOTIDINE RELATED COMPOUND B FAMOTIDINE RELATED COMPOUND B 89268-62-2 C16H23N11O2S5
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