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:
- Ibrutinib Impurity 3
- CAS:
- 1226872-27-0
- MF:
- C25H26N6O4
- Structure:
- Chemical Name:
- Imatinib Impurity 2
- CAS:
- 1384131-91-2
- MF:
- C7H11NO
- Structure:
- Chemical Name:
- Mirabegron M5 (YM-538852)
- CAS:
- 1365244-63-8
- MF:
- C18H22N2O2
- Chemical Name:
- Sofosbuvir Impurity 6
- Structure:
- Chemical Name:
- Vonoprazan Impurity 2
- CAS:
- 881733-36-4
- MF:
- C17H16FN3O2S
- Structure:
- Chemical Name:
- Atomoxetine EP impurity A
- CAS:
- 56161-70-7
- MF:
- C16H19NO
- Chemical Name:
- Cinacalcet Impurity 21
- Chemical Name:
- Dasatinib Impurity D
- Structure:
- Chemical Name:
- Doxofylline Impurity 1
- CAS:
- 1429636-74-7
- MF:
- C10H16N4O3
- Structure:
- Chemical Name:
- Isopropyl4-hydroxy-3,5-diisopropylbenzoate
- CAS:
- 2095678-97-8
- MF:
- C16H24O3
- Structure:
- Chemical Name:
- Sitagliptin EP Impurity B
- CAS:
- 1345822-87-8
- MF:
- C16H19F5N5O5P
- Chemical Name:
- Trospium Impurity
- Structure:
- Chemical Name:
- Vildagliptin Related Compound A
- CAS:
- 741657-02-3
- MF:
- C17H25N3O
- Structure:
- Chemical Name:
- 2-amino-9-((1R,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl)-1,9-dihydro-6H-purin-6-one hydrate
- CAS:
- 1367369-78-5
- MF:
- C12H15N5O3
- Structure:
- Chemical Name:
- Moxifloxacin Impurity 6
- CAS:
- 849770-49-6
- MF:
- C25H29BFN3O8
- Structure:
- Chemical Name:
- Sitafloxacin Impurity A
- CAS:
- 500295-83-0
- MF:
- C16H16FN3O3
- Structure:
- Chemical Name:
- 1-benzylpiperidin-4-yl [1,1'-biphenyl]-2-ylcarbamate
- CAS:
- 171723-80-1
- MF:
- C25H26N2O2
- Chemical Name:
- Merariveron impurity C
- Structure:
- Chemical Name:
- methyl (Z)-3-(((4-(2-(4-(2-((4-((((Z)-6-(methoxymethyl)-2-oxoindolin-3-ylidene)(phenyl)methyl)amino)phenyl)(methyl)amino)-2-oxoethyl)piperazin-1-yl)-N-methylacetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate
- CAS:
- 2097505-01-4
- MF:
- C56H54N8O7
- Structure:
- Chemical Name:
- Roxithromycin EP Impurity J
- CAS:
- 134834-12-1
- MF:
- C40H73ClN2O14
- Structure:
- Chemical Name:
- Venlafaxine D6
- CAS:
- 940297-06-3
- MF:
- C17H27NO2
- Chemical Name:
- Levosimendan Impurity 3
- Chemical Name:
- Sofosbuvir Impurity29
- Chemical Name:
- Acarbose Impurity A
- Structure:
- Chemical Name:
- Levosimendan Impurity 1
- CAS:
- 1643439-59-1
- MF:
- C22H23N7O2
- Chemical Name:
- Atomoxetine EP Impurity F
- Chemical Name:
- Quetiapine EP Impurity Q
- Chemical Name:
- Cefoxitin Impurity
- Chemical Name:
- Acemetacin Impurity
- Structure:
- Chemical Name:
- ethyl (S)-6,7,8-trifluoro-1-(1-hydroxypropan-2-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylate
- CAS:
- 110548-03-3
- MF:
- C15H14F3NO4
- Structure:
- Chemical Name:
- ethyl (E)-2-(2-(4-methoxyphenyl)hydrazono)propanoate
- CAS:
- 4792-57-8
- MF:
- C12H16N2O3
- Structure:
- Chemical Name:
- ACT 373898
- CAS:
- 1433875-14-9
- MF:
- C15H17BrN4O5S
- Structure:
- Chemical Name:
- Reaxys ID: 3623864
- CAS:
- 129385-61-1
- MF:
- C17H10ClNO3
- Chemical Name:
- Olaparib Impurity D
- Structure:
- Chemical Name:
- 1-methylpyrrolidin-3-yl 2-(cyclopentyloxy)-2-phenylacetate
- MF:
- C18H25NO3
- Chemical Name:
- Cabozantinib impurity A
- Structure:
- Chemical Name:
- Loratadine Impurity 2
- MF:
- C22H23ClN2O2
- Structure:
- Chemical Name:
- Metoprolol Impurity 1
- MF:
- C15H25NO3
- Chemical Name:
- Pitavastatin Impurity 1
- Chemical Name:
- Trifluridine Impurity 3
- Chemical Name:
- Vonoprazan Impurity 1
- Chemical Name:
- Vonoprazan Impurity 4
- Chemical Name:
- Cinacalcet impurity K
- Structure:
- Chemical Name:
- Valsartan Impurity 13
- MF:
- C24H29N5O3
- Structure:
- Chemical Name:
- Valsartan Impurity 27
- MF:
- C24H29N5O3
- Chemical Name:
- Etoricoxib Impurity 6
- Chemical Name:
- Ezetimibe impurity 3
- Chemical Name:
- Apremilast Impurity C
- Structure:
- Chemical Name:
- bis(1-benzylpiperidin-3-yl) 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
- CAS:
- 166808-97-5
- MF:
- C16H16N2O6
- Structure:
- Chemical Name:
- Ticagrelor Imp.J
- CAS:
- 2248538-63-6
- MF:
- C14H20ClN5O4S
- Structure:
- Chemical Name:
- Vortioxetine Imp.E
- CAS:
- 508233-77-0
- MF:
- C18H22N2S
- Structure:
- Chemical Name:
- (3R,4S)-1-(4-fluorophenyl)-3-((S)-3-hydroxy-3-(p-tolyl)propyl)-4-(4-hydroxyphenyl)azetidin-2-one
- CAS:
- 1700622-07-6
- MF:
- C25H24FNO3
- Chemical Name:
- Topiroxostat Impurity 1
- Chemical Name:
- Oxcarbazepine Impurity3
- Chemical Name:
- Ondansetron Impurity B
- Structure:
- Chemical Name:
- LeflunoMide EP IMpurity F
- CAS:
- 1403564-06-6
- MF:
- C12H9F3N2O2
- Structure:
- Chemical Name:
- ((R)-3-Methyl-1-((R)-3-phenyl-2-(pyrazine-2-carboxaMido)propanaMido)butyl)boronic acid
- CAS:
- 1132709-15-9
- MF:
- C19H25BN4O4
- Structure:
- Chemical Name:
- (S)-N-(1-AMino-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide
- CAS:
- 289472-80-6
- MF:
- C14H14N4O2
- Structure:
- Chemical Name:
- (3aS,4R,6S,6aR)-6-AMinotetrahydro-2,2-diMethyl-4H-cyclopenta-1,3-dioxol-4-ol
- CAS:
- 592533-90-9
- MF:
- C8H15NO3
- Structure:
- Chemical Name:
- (4R,6S)-tert-Butyl-6-cyanoMethyl-2,2-diMethyl-1,3-dioxane-4-acetate
- CAS:
- 196085-84-4
- MF:
- C14H23NO4
- Structure:
- Chemical Name:
- (1R,2R,3S,5R)-3-(7-((1S,2R)-2-(3,4-difluorophenyl)cyclopropylaMino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
- CAS:
- 2096989-55-6
- MF:
- C23H28F2N6O4S
- Structure:
- Chemical Name:
- Rivaroxaban iMpurity
- CAS:
- 1616563-62-2
- MF:
- C15H17N3O5
- Structure:
- Chemical Name:
- AMoxicillin iMpurity K
- MF:
- C16H19N3O5S
- Chemical Name:
- cefoxitin iMpurity D
- Structure:
- Chemical Name:
- 3-Morpholinone, 4-(2,4-diaMinophenyl)-
- CAS:
- 482308-13-4
- MF:
- C10H13N3O2
- Structure:
- Chemical Name:
- BenzenesulfonaMide, N-[1,6-dihydro-5-(2-Methoxyphenoxy)-6-oxo[2,2'-bipyriMidin]-4-yl]-4-(1,1-diMethylethyl)-
- CAS:
- 174227-14-6
- MF:
- C25H25N5O5S
- Structure:
- Chemical Name:
- BenzaMide, N-[1-(3,5-di-O-benzoyl-2-C-Methyl-β-D-arabinofuranosyl)-1,2-dihydro-2-oxo-4-pyriMidinyl]-
- CAS:
- 863329-62-8
- MF:
- C31H27N3O8
- Chemical Name:
- Fosfluconazole iMpurity
- Structure:
- Chemical Name:
- Cinacalcet Impurity D
- CAS:
- 1271930-15-4
- MF:
- C32H31F6N
- Structure:
- Chemical Name:
- AtracuriuM IMpurity D2 (cis-Quaternary Alcohol)
- CAS:
- 1100676-16-1
- MF:
- C35H47NO10S
- Chemical Name:
- AzithroMycin IMpurity O
- Structure:
- Chemical Name:
- BendaMustine Dihydroxy IMpurity
- CAS:
- 109882-29-3
- MF:
- C16H24ClN3O4
- Structure:
- Chemical Name:
- BroMocriptine IMpurity G
- MF:
- C32H40BrN5O5
- Structure:
- Chemical Name:
- Captopril IMpurity H
- CAS:
- 205521-07-9
- MF:
- C15H23NO5S2
- Structure:
- Chemical Name:
- Cefdinir IMpurity 3 (Cefdinir Decarboxy Open Ring Lactone (Mixture of A and B))
- CAS:
- 178949-04-7
- MF:
- C13H15N5O4S2
- Chemical Name:
- Ceftriaxone IMpurit D
- Structure:
- Chemical Name:
- Ciprofloxacin Related CoMpound
- CAS:
- 528851-30-1
- MF:
- C15H17Cl2N3O3
- Chemical Name:
- Dasatinib IMpurity 4
- Structure:
- Chemical Name:
- Deferasirox Methyl Ester
- CAS:
- 1266741-05-2
- MF:
- C22H17N3O4
- Structure:
- Chemical Name:
- Deltacortinene Acetate (Predisolone Acetate IMpurity)
- CAS:
- 4380-55-6
- MF:
- C23H28O5
- Chemical Name:
- Entecavir IMpurity A
- Structure:
- Chemical Name:
- Fasudil IMpurity 1
- CAS:
- 1423155-03-6
- MF:
- C14H17N3O2S
- Structure:
- Chemical Name:
- Irbesartan IMpurity
- CAS:
- 1079997-01-5
- MF:
- C26H30N6O2
- Chemical Name:
- Montelukast EP IMpurity I
- Structure:
- Chemical Name:
- RaceMic Fudosteine HCl
- CAS:
- 1023971-15-4
- MF:
- C6H13NO3S
- Chemical Name:
- RocuroniuM BroMide IMpurity 18
- Structure:
- Chemical Name:
- SalMeterol IMpurity E
- MF:
- C25H37NO4
- Chemical Name:
- SulbactaM IMpurity C
- Structure:
- Chemical Name:
- Terazosin IMpurity J
- CAS:
- 152551-75-2
- MF:
- C19H27N5O4
- Structure:
- Chemical Name:
- Ticarcillin SodiuM IMpurity A
- CAS:
- 36041-93-7
- MF:
- C14H16N2O4S2
- Structure:
- Chemical Name:
- R-afatinib
- CAS:
- 945553-91-3
- MF:
- C24H25ClFN5O3
- Structure:
- Chemical Name:
- EthanediaMide iMpurity E
- MF:
- C2H4N2O2
- Chemical Name:
- Mosapride IMP
- Structure:
- Chemical Name:
- 4-Ethoxy Paroxetine
- CAS:
- 606968-04-1
- MF:
- C21H25NO4
- Structure:
- Chemical Name:
- Methylene-Bis Paroxetine
- CAS:
- 1292846-10-6
- MF:
- C39H40F2N2O6
- Structure:
- Chemical Name:
- Trelagliptin Impurity X
- CAS:
- 1938080-44-4
- MF:
- C18H22FN5O3
- Structure:
- Chemical Name:
- Afatinib Impurity 19
- CAS:
- 1245555-42-3
- MF:
- C21H21ClFN5O2
- Chemical Name:
- Cefoxitin Sodium impurity
- Structure:
- Chemical Name:
- (1S,2S,3S)-Aprepitant
- CAS:
- 1242175-40-1
- MF:
- C23H21F7N4O3
- Structure:
- Chemical Name:
- 2-{[(methoxycarbonylmethyl)(toluene-4-sulfonyl)amino]methyl}-4-phenoxybenzoic acid methyl ester
- CAS:
- 1455091-06-1
- MF:
- C25H25NO7S