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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
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
OCTAKIS-6-BROMO-6-DEOXY-GAMMA-CYCLODEXTRIN OCTAKIS-6-BROMO-6-DEOXY-GAMMA-CYCLODEXTRIN 53784-84-2 C48H72Br8O32
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
2-Ethynylaniline 2-Ethynylaniline 52670-38-9 C8H7N
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
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
NICERGOLINE IMPURITY A NICERGOLINE IMPURITY A
AZITHROMYCIN IMPURITY B AZITHROMYCIN IMPURITY B 307974-61-4 C38H72N2O11
1026009-77-7 1026009-77-7 1026009-77-7 C20H22N2O
α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile 120512-38-1 C14H16N2
α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile α,α,α'',5-Tetramethyl-1,3-benzenediacetonitrile 120512-38-1 C14H16N2
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
Azlocillin dioxide Impurity Azlocillin dioxide Impurity
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
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
Alogliptin Impurity 7 Alogliptin Impurity 7
Alogliptin Impurity 7 Alogliptin Impurity 7
diethyl 2-(2-bromoethyl)-malonate diethyl 2-(2-bromoethyl)-malonate 18721-64-7 C9H15BrO4
methyl 2,5-dihydroxybenzenesulfonate methyl 2,5-dihydroxybenzenesulfonate C7H8O5S
Pinocembroside,Pinocembrin41-O-beta-D-glucoside Pinocembroside,Pinocembrin41-O-beta-D-glucoside
4-(1-(dimethylamino)ethyl)phenyl ethyl(methyl)carbamate 2,3- dihydroxysuccinate 4-(1-(dimethylamino)ethyl)phenyl ethyl(methyl)carbamate 2,3- dihydroxysuccinate 123441-05-4 C14H22N2O2
Dapagliflozin mono acetyl impurity Dapagliflozin mono acetyl impurity 1632287-34-3 C23H27ClO7
Piperacillin Impurity 3 Piperacillin Impurity 3
Varenicline Impurity 5 Varenicline Impurity 5 950781-87-0 C11H13N3O2
4-MORPHOLIN-4-YL-1,2,5-THIADIAZOL-3-OL 4-MORPHOLIN-4-YL-1,2,5-THIADIAZOL-3-OL 30165-97-0 C6H9N3O2S
Amlodipine Impurity 29 Amlodipine Impurity 29 93848-82-9 C22H27ClN2O6
Amlodipine Impurity 34 Amlodipine Impurity 34 C26H31ClN2O8S
1-benzyl-4-(piperidin-1-yl)-1,2,3,6-tetrahydropyridine 1-benzyl-4-(piperidin-1-yl)-1,2,3,6-tetrahydropyridine 53877-76-2 C17H24N2
propan-2-yl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate propan-2-yl 2-[(4R,6R)-6-{2-[2-(4-fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]ethyl}-2,2-dimethyl-1,3-dioxan-4-yl]acetate 1112262-71-1 C39H45FN2O5
Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-9,11-epoxy-16,17-dihydroxy-, (9β,11β,16α)- Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-9,11-epoxy-16,17-dihydroxy-, (9β,11β,16α)- 58404-37-8 C23H28O7
TYRPHOSTIN AG 1290 TYRPHOSTIN AG 1290 160391-70-8 C10H6N2O6
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
Palbociclib Impurity 91 Palbociclib Impurity 91 571191-15-6 C22H27N7O2
Ibrutinib Impurity 28 Ibrutinib Impurity 28 2213398-75-3 C18H15N5O
Clopidogrel Impurity 60 Clopidogrel Impurity 60 1430373-12-8 C25H26ClNO6S
Ozagrel Impurity F Ozagrel Impurity F
Ceftriaxone Sodium impurity 1 Ceftriaxone Sodium impurity 1 1214622-93-1 C10H12N2O5S
Lasoprazole impurity Lasoprazole impurity
2-bromo-1-(4-chlorothiophen-2-yl)ethanone 2-bromo-1-(4-chlorothiophen-2-yl)ethanone 677007-73-7 C6H4BrClOS
Fluticasone Impurity 14 Fluticasone Impurity 14 C25H31F3O5S
Ritonavir EP Impurity U Ritonavir EP Impurity U
((3R,5S)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenyl
carbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate)calcium(II)
((3R,5S)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenyl carbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate)calcium(II) C66H68CaF2N4O10
DexMedetoMidine IMpurity O DexMedetoMidine IMpurity O
Rivaroxaban Impurity 48 Rivaroxaban Impurity 48 1414932-72-1 C21H20ClN3O4
Imatinib Impurity A Imatinib Impurity A
Vonoprazan Impurity 19 Vonoprazan Impurity 19
Pregabalin Diacid Pregabalin Diacid 1788341-42-3 C16H26N2O
Dexamethasone Impurity A Dexamethasone Impurity A
Olaparib Impurity 24 Olaparib Impurity 24
Topiroxostat Impurity 6 Topiroxostat Impurity 6
Irinotecan EP Impurity H Irinotecan EP Impurity H
Teneligliptin Impurity 4 Teneligliptin Impurity 4
7-(2-methoxypropanoyl)-5H-chromeno[2,3-b]pyridin-5-one 7-(2-methoxypropanoyl)-5H-chromeno[2,3-b]pyridin-5-one
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
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
TIZOXANIDE GLUCURONIDE, SODIUM SALT TIZOXANIDE GLUCURONIDE, SODIUM SALT 221287-83-8 C16H14N3NaO10S
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