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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- Chemical Name:
- Itraconazole iMpurity 6
- Structure:
- Chemical Name:
- Ribavirin API Impurity O
- CAS:
- 799-87-1
- MF:
- C13H11N2O8P
- Chemical Name:
- Aprepitant Impurity 14
- Chemical Name:
- Trelagliptin Impurity 16
- Chemical Name:
- Decitabine Impurity 7
- Chemical Name:
- Fosaprepitant Impurity 6
- Chemical Name:
- Dapoxetine Impurity 6
- Chemical Name:
- Regorafenib Impurity 13
- Chemical Name:
- Topiroxostat Impurity 4
- Chemical Name:
- Bosutinib Impurity 8
- Chemical Name:
- Ticagrelor Impurity 13
- Chemical Name:
- Ticagrelor Impurity 66
- Chemical Name:
- Canagliflozin Impurity 8
- Chemical Name:
- Canagliflozin Impurity 16
- Chemical Name:
- Oseltamivir Impurity 12
- Chemical Name:
- Oseltamivir Impurity 32
- Chemical Name:
- Riociguat IMpurtiy E
- Structure:
- Chemical Name:
- Meropenem impurity diastereomer 2
- CAS:
- 96035-15-3
- MF:
- C15H19N3O5S
- Structure:
- Chemical Name:
- N-METHYL-3-CHLORO-3-PHENYL PROPYLAMINE HCL
- CAS:
- 128036-32-8
- MF:
- C10H15Cl2N
- Structure:
- Chemical Name:
- 3-Methoxy-2,4,5-trifluorobenzoic acid
- CAS:
- 11281-65-5
- MF:
- C8H5F3O3
- Structure:
- Chemical Name:
- METHYL TRIPHENYLMETHYL ETHER
- CAS:
- 596-31-6
- MF:
- C20H18O
- Chemical Name:
- Nintedanib Impurity 26
- Chemical Name:
- N-Formyl impurity
- Structure:
- Chemical Name:
- (3R,4R)-N,1,4-trimethyl-N-{7H-pyrrolo[2,3-d]pyrimidin-4-yl}piperidin-3-amine
- CAS:
- 2227197-38-6
- MF:
- C14H21N5
- Chemical Name:
- Varenicline Impurity 1
- Structure:
- Chemical Name:
- Amlodipine Impurity 27 Disodium Salt
- CAS:
- 120289-11-4
- MF:
- C19H20ClNO7
- Chemical Name:
- Erlotinib Impurity 47 HCl
- Chemical Name:
- Etoricoxib Impurity 33
- Structure:
- Chemical Name:
- 2,2-dichloro-N-(2,3-dimethylphenyl)acetamide
- CAS:
- 18823-63-7
- MF:
- C10H11Cl2NO
- Structure:
- Chemical Name:
- 2-(1-HydroxyCyclohexyl)-2-(4-MethoxyPhenyl)Acetonitrile
- CAS:
- 93413-76-4
- MF:
- C15H19NO2
- Chemical Name:
- Clindamycin Impurity A
- Chemical Name:
- Tigecycline Impurity F
- Chemical Name:
- Fasudil iMpurity A
- Chemical Name:
- Cefminox Impurity C
- Structure:
- Chemical Name:
- 4,5-Dibromo-1,2-benzenediol
- CAS:
- 2563-26-0
- MF:
- C6H4Br2O2
- Structure:
- Chemical Name:
- CLOPIDOGREL CARBOXYLIC ACID
- CAS:
- 144457-28-3
- MF:
- C15H14ClNO2S
- Structure:
- Chemical Name:
- RAC (CIS/TRANS) DONEPEZIL N-OXIDE
- CAS:
- 120013-84-5
- MF:
- C24H29NO4
- Structure:
- Chemical Name:
- 5-Carboxy-2'-deoxyuridine
- CAS:
- 14599-46-3
- MF:
- C10H12N2O7
- Structure:
- Chemical Name:
- BENZENE ACETIC ACID, 4-[(2-CARBOXYPHENYL)METHOXY]
- CAS:
- 55453-89-9
- MF:
- C16H14O5
- Chemical Name:
- Ipragliflozin Impurity 5
- Structure:
- Chemical Name:
- Alectinib Impurity
- CAS:
- 1256584-83-4
- MF:
- C26H25N3O2
- Structure:
- Chemical Name:
- Afatinib impurity 11/Des-(4-dimethylamino-2-en-1-oxo)butylamino 6-(5-Hydroxy-pyrrolidin-2-on-1-yl) Afatinib
- CAS:
- 2223677-58-3
- MF:
- C22H20ClFN4O4
- Structure:
- Chemical Name:
- Ibrutinib Impurity 18
- CAS:
- 1881246-01-0
- MF:
- C16H12N4O
- Structure:
- Chemical Name:
- Vitamin B1 Impurity 6
- MF:
- C12H17ClN4OS
- Structure:
- Chemical Name:
- 5,5'-((tert-butylazanediyl)bis(1-hydroxyethane-2,1-diyl))bis(benzene- 1,3-diol)
- MF:
- C20H27NO6
- Structure:
- Chemical Name:
- 2,2'-difluoro-3,3'-dimethoxy-1,1'-biphenyl
- CAS:
- 2316733-82-9
- MF:
- C14H12F2O2
- Chemical Name:
- nicergoline impurity N
- Structure:
- Chemical Name:
- Clopidogrel Impurity 50
- MF:
- C15H14ClNO2S
- Chemical Name:
- PraMipexole IMpurity Z1/Z2
- Structure:
- Chemical Name:
- trans-Ibuprofen Impurity G
- MF:
- C13H18O2
- Chemical Name:
- Vonoprazan Impurity 15
- Chemical Name:
- Esomeprazole Impurity 6
- Chemical Name:
- Erlotinib Impurity 22
- Chemical Name:
- Teneligliptin Impurity 1
- Structure:
- Chemical Name:
- Benzene, 1-chloro-2-(dimethoxymethyl)-
- CAS:
- 70380-66-4
- MF:
- C9H11ClO2
- Structure:
- Chemical Name:
- (R)-1-chloro-3-{[(4-chlorophenyl)methylene]amino}propan-2-ol
- CAS:
- 1450915-93-1
- MF:
- C10H11Cl2NO
- Structure:
- Chemical Name:
- 3-(trifluoromethyl)-6,7-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-8(5H)-one
- CAS:
- 877402-45-4
- MF:
- C6H5F3N4O
- Structure:
- Chemical Name:
- 4-((5,6-dimethoxy-1H-inden-2-yl)methyl)piperidine
- CAS:
- 1026443-48-0
- MF:
- C17H23NO2
- Structure:
- Chemical Name:
- epipinoresinol-4'-O-β-D-glucoside
- CAS:
- 24404-49-7
- MF:
- C26H32O11
- Structure:
- Chemical Name:
- Celecoxib Impurity
- CAS:
- 170570-09-9
- MF:
- C18H16F3N3O2S
- Structure:
- Chemical Name:
- NMEICKDXQPVPKK-UHFFFAOYSA-N
- CAS:
- 120244-82-8
- MF:
- C16H19ClN2O
- Structure:
- Chemical Name:
- 4-Methylpiperazine-1-carbonyl chloride
- CAS:
- 39539-66-7
- MF:
- C6H11ClN2O
- Structure:
- Chemical Name:
- Epoxy Exemestane (6-Beta Isomer)
- CAS:
- 152764-31-3
- MF:
- C20H24O3
- Structure:
- Chemical Name:
- AFTMPFJWAIDLME-QWHCGFSZSA-N
- CAS:
- 1808087-53-7
- MF:
- C15H19N3O3S
- Structure:
- Chemical Name:
- 6-Cyclopropyl-10-fluorobenzo[k]phenanthridine
- CAS:
- 1187966-95-5
- MF:
- C20H14FN
- Structure:
- Chemical Name:
- 4-[2-fluoro-4-[2-(methylcarbamoyl)pyridin-4-yl]oxyanilino]-N-methylpyridine-2-carboxamide
- CAS:
- 1855006-12-0
- MF:
- C20H18FN5O3
- Structure:
- Chemical Name:
- 2,2'-((piperazine-1,4-disulfonyl)bis(2-ethoxy-5,1-phenylene))bis(5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(3H)-one)
- CAS:
- 1255919-03-9
- MF:
- C38H46N10O8S2
- Chemical Name:
- Bortezomib Impurity P
- Chemical Name:
- Esmolol impurity A
- Structure:
- Chemical Name:
- (5-(4-fluorophenyl)thiophen-2-yl)(5-iodo-2-methylphenyl)methanol
- CAS:
- 1818268-45-9
- MF:
- C18H14FIOS
- Structure:
- Chemical Name:
- 2-propyl-1H-indene-1,3(2H)-dione
- CAS:
- 14570-43-5
- MF:
- C12H12O2
- Structure:
- Chemical Name:
- GLORIOSINE
- CAS:
- 7411-12-3
- MF:
- C21H23NO6
- Structure:
- Chemical Name:
- Labetalone hydrochloride
- CAS:
- 96441-14-4
- MF:
- C19H22N2O3.ClH
- Structure:
- Chemical Name:
- 6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)- 7,9-dimethyl-7,9-dihydro-8H-purin-8-one
- CAS:
- 1361569-23-4
- MF:
- C20H17FN8O
- Structure:
- Chemical Name:
- 5-(1-amino-2-(methylsulfonyl)ethyl)-2-methoxyphenol
- CAS:
- 2169153-70-0
- MF:
- C10H15NO4S
- Chemical Name:
- Bendamustine Impurity 14
- Chemical Name:
- Canagliflozin Impurity 28
- Chemical Name:
- Erlotinib Hydrochloride iMpurity 51
- Structure:
- Chemical Name:
- (S)-10-(1-aminocyclopropyl)-3-methyl-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid formic acid
- MF:
- C17H18N2O6
- Structure:
- Chemical Name:
- 1H-Imidazole-1-ethanol, α-(chloromethyl)-5-nitro-
- CAS:
- 116989-52-7
- MF:
- C6H8ClN3O3
- Structure:
- Chemical Name:
- 4-Pyridinemethanol, 3-hydroxy-2,5-dimethyl-, hydrochloride (1:1)
- CAS:
- 875-26-3
- MF:
- C8H11NO2.ClH
- Chemical Name:
- Afatinib ImpurityOYQ
- Structure:
- Chemical Name:
- Androst-3-en-17-one,(5)
- CAS:
- 14935-81-0
- MF:
- C19H28O
- Chemical Name:
- Landiolol impurity X
- Chemical Name:
- 2-((4-(3-aminopiperidin-1-yl)
- Chemical Name:
- Rosuvastatin Impurity 111
- Structure:
- Chemical Name:
- Metoprolol IMpurity V
- MF:
- C15H25NO3
- Chemical Name:
- Teneligliptin Impurity 12
- Chemical Name:
- Nicergoline EP Impurity E
- Structure:
- Chemical Name:
- Hexanoic acid, 3-[(hydroxyamino)methyl]-5-methyl-, (3S)-
- CAS:
- 2349671-57-2
- MF:
- C8H17NO3
- Structure:
- Chemical Name:
- α-D-Glucopyranoside, methyl 1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, 2,3,4,6-tetraacetate
- CAS:
- 714269-58-6
- MF:
- C30H35ClO11
- Chemical Name:
- Caspofungin Impurity H
- Structure:
- Chemical Name:
- (trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4-methoxyphenyl)-1-methylpiperidine hydrochloride
- CAS:
- 127017-41-8
- MF:
- C21H26ClNO4
- Structure:
- Chemical Name:
- Ezetimibe Impurity 76
- CAS:
- 1185883-46-8
- MF:
- C39H44F2N2O5Si
- Structure:
- Chemical Name:
- Cefmetazole impurity 9/(6R-cis)-7-[[[(Cyanomethyl)thio]acetyl]amino]-3-(hydroxymethyl)-7-methoxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
- CAS:
- 70953-19-4
- MF:
- C13H15N3O6S2
- Structure:
- Chemical Name:
- ((cis)-4-(4-fluorophenyl)-1-methylpiperidin-3-yl)methyl 4-methylbenzenesulfonate
- MF:
- C20H24FNO3S
- Chemical Name:
- Elagolix Sodium impurity1
- Structure:
- Chemical Name:
- Ibrutinib Impurity 37
- CAS:
- 330793-49-2
- MF:
- C10H13IN6
- Structure:
- Chemical Name:
- (S)-((6-(propylamino)-4,5,6,7-tetrahydrobenzo[d]thiazol-2-yl)amino)methanol
- MF:
- C11H19N3OS
- Structure:
- Chemical Name:
- (trans)-4-((6-amino-2,3-dibromobenzyl)amino)cyclohexanol
- MF:
- C13H18Br2N2O