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:
- DiazepaM IMpurity F
- CAS:
- 31269-33-7
- MF:
- C16H13ClN2O
- Chemical Name:
- LaMotrigine IMpurity
- Structure:
- Chemical Name:
- 2-(DiethylaMino)-N-(2,3-diMethylphenyl)acetaMide Hydrochloride
- CAS:
- 857170-72-0
- MF:
- C14H23ClN2O
- Structure:
- Chemical Name:
- 4-Hydroxy Darunavir
- CAS:
- 313682-97-2
- MF:
- C27H37N3O8S
- Structure:
- Chemical Name:
- Deschloroaripiprazole
- CAS:
- 203395-81-7
- MF:
- C23H28ClN3O2
- Structure:
- Chemical Name:
- O-[(Guanin-9-yl)Methyl] Acyclovir
- CAS:
- 166762-90-9
- MF:
- C14H16N10O4
- Chemical Name:
- Paroxetine IMpurity
- CAS:
- 105813-23-8
- Structure:
- Chemical Name:
- 7-[(2-aMinoethyl)aMino] -1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
- MF:
- C14H16FN3O3
- Structure:
- Chemical Name:
- (S)-(1R,3s,5S)-8-Methyl-8-azabicyclo[3.2.1]oct-6-en-3-yl 3-hydroxy-2-phenylpropanoate
- CAS:
- 61616-97-5
- MF:
- C17H21NO3
- Structure:
- Chemical Name:
- 3-(4-Carboethoxy)phenyl propanal
- CAS:
- 151864-81-2
- MF:
- C12H14O3
- Structure:
- Chemical Name:
- (2,6-Xylyloxy)acetyl Lopinavir
- CAS:
- 943250-65-5
- MF:
- C47H58N4O7
- Chemical Name:
- AlviMopan iMpurity
- Chemical Name:
- Caspofungin iMpurity
- Structure:
- Chemical Name:
- Saxagliptin iMpurity
- CAS:
- 2173146-35-3
- MF:
- C18H24ClN3O2
- Structure:
- Chemical Name:
- Chlorocriptine
- CAS:
- 68944-88-7
- MF:
- C32H40ClN5O5
- Structure:
- Chemical Name:
- PD 312237
- CAS:
- 501666-23-5
- MF:
- C20H35NO11
- Structure:
- Chemical Name:
- (1R,5S,6S)-rel-5-(1-Ethylpropoxy)-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Methyl Ester
- CAS:
- 1234858-94-6
- MF:
- C13H20O4
- Structure:
- Chemical Name:
- Salmeterol Related Compound B (10 mg) (4-{1-Hydroxy-2-[6-(4-phenylbutan-2-yloxy)hexylamino]ethyl}-2-(hydroxymethyl)phenol)
- CAS:
- 108928-81-0
- MF:
- C25H37NO4
- Structure:
- Chemical Name:
- 7-ethyl-5H-chroMeno[2,3-b]pyridin-5-one
- CAS:
- 53944-31-3
- MF:
- C14H11NO2
- Structure:
- Chemical Name:
- 2-Methyl-10H-thieno[2,3-b][1,5]benzodiazepin-4-aMine
- CAS:
- 612503-08-9
- MF:
- C12H11N3S
- Structure:
- Chemical Name:
- 21-Dehydro-16α-hydroxy Prednisolone
- CAS:
- 1188271-73-9
- MF:
- C21H26O6
- Structure:
- Chemical Name:
- (6α,11β)-11,20-Dihydroxy-6-Methyl-3-oxopregna-1,4,17(20)-trien-21-al
- CAS:
- 1338549-02-2
- MF:
- C22H28O4
- Structure:
- Chemical Name:
- (1R)-2-chloro-1-(3,4-difluorophenyl)-1-ethanol
- CAS:
- 1212376-05-0
- MF:
- C8H7ClF2O
- Structure:
- Chemical Name:
- 2-[[(3aR,4S,6R,6aS)-6-[7-Chloro-5-(propylthio)-3H-1,2,3-triazolo[4,5-d]pyrimidin-3-yl]tetrahydro-2,2-dimethyl-4H-cyclopenta-1,3-dioxol-4-yl]oxy]-ethanol
- CAS:
- 376608-75-2
- MF:
- C17H24ClN5O4S
- Structure:
- Chemical Name:
- Fluconazole IMpurity F
- MF:
- C13H12F2N6O
- Structure:
- Chemical Name:
- Erlotinib IMpurity A
- CAS:
- 1058132-82-3
- MF:
- C22H25N3O4
- Chemical Name:
- Apixaban iMpurity 5
- Structure:
- Chemical Name:
- cefaclor iMpurity C
- CAS:
- 143059-69-2
- MF:
- C15H14ClN3O4S
- Chemical Name:
- ceftazidiMe iMpurity B
- CAS:
- 1236700-64-3
- Structure:
- Chemical Name:
- pidotiMod iMpurity D
- CAS:
- 162148-15-4
- MF:
- C9H12N2O4S
- Structure:
- Chemical Name:
- Irinotecan Hydroxyl Acid
- CAS:
- 142677-15-4
- MF:
- C22H22N2O6
- Structure:
- Chemical Name:
- CyclopropanaMine, 2-(4-fluorophenyl)-(hydrochloride)(1:1),(1R,2S)-
- CAS:
- 1314324-00-9
- MF:
- C9H11ClFN
- Structure:
- Chemical Name:
- (1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(3,4-difluorophenyl)cyclopropyl)aMino)-5-(propylsulfinyl)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
- CAS:
- 1644461-85-7
- MF:
- C23H28F2N6O5S
- Chemical Name:
- AtracuriuM IMpurity C (Mixture of DiastereoMers)
- CAS:
- 86293-35-8
- Chemical Name:
- AtracuriuM IMpurity E (cis-Quaternary Acid)
- Chemical Name:
- AztreonaM IMpurity B
- Chemical Name:
- Ceftriaxone IMpurit E
- Structure:
- Chemical Name:
- Cetirizine IMpurity-6
- MF:
- C21H25ClN2O3
- Structure:
- Chemical Name:
- Cinacalcet IMpurity 10
- CAS:
- 1809324-40-0
- MF:
- C29H28F3NO2S
- Chemical Name:
- Dasatinib IMpurity 5
- Structure:
- Chemical Name:
- Diacerein IMpurity F
- CAS:
- 13928-72-8
- MF:
- C35H36O16
- Structure:
- Chemical Name:
- D-Valganciclovir Hydrochloride
- CAS:
- 1393911-57-3
- MF:
- C14H23ClN6O5
- Chemical Name:
- Entecavir IMpurity E
- Structure:
- Chemical Name:
- EzetiMibe IMpurity 1
- CAS:
- 190595-66-5
- MF:
- C24H22FNO3
- Structure:
- Chemical Name:
- Flurbiprofen IMpurity B
- CAS:
- 1797883-74-9
- MF:
- C18H17FO4
- Chemical Name:
- IMatinib DiPiperidine IMpurity
- Chemical Name:
- levocetirizine IMpurity
- Structure:
- Chemical Name:
- N-Ethyl Tadalafil
- CAS:
- 1609405-34-6
- MF:
- C23H21N3O4
- Chemical Name:
- OseltaMivir IMpurity F
- Chemical Name:
- RocuroniuM BroMide IMpurity 19
- Structure:
- Chemical Name:
- S-(+)-O-DesMethyl-Venlafaxine-d6
- CAS:
- 1062609-99-7
- MF:
- C16H25NO2
- Structure:
- Chemical Name:
- SalMeterol IMpurity F
- MF:
- C25H37NO4
- Structure:
- Chemical Name:
- N-Trityl Candesartan Ethyl Ester
- CAS:
- 856414-35-2
- MF:
- C45H38N6O3
- Structure:
- Chemical Name:
- 3R,4S-4-(4-methoxyphenyl)-1-methylpiperi dinyl] methanol
- CAS:
- 127017-78-1
- MF:
- C14H21NO2
- Structure:
- Chemical Name:
- 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(1R,3S,4R)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-
- CAS:
- 188399-46-4
- MF:
- C12H15N5O3
- Structure:
- Chemical Name:
- 4,4'-(2-HYDROXY-1,3-PROPANDIYLDIOXY)BIS(2-PHENYLACETAMIDE)
- CAS:
- 141650-31-9
- MF:
- C19H22N2O5
- Structure:
- Chemical Name:
- Valsartan cyano analog methyl ester
- CAS:
- 137863-90-2
- MF:
- C25H30N2O3
- Structure:
- Chemical Name:
- (8S)-2-BroMo α-Ergocryptine
- CAS:
- 65700-36-9
- MF:
- C32H40BrN5O5
- Structure:
- Chemical Name:
- 3-[4-(4-Chlorobenzoyl)phenoxy]-2-butanone (Fenofibrate IMpurity)
- CAS:
- 217636-47-0
- MF:
- C17H15ClO3
- Structure:
- Chemical Name:
- 5-(2-Chlorobenzyl)-thieno[3,2-c]pyridiniuM Chloride
- CAS:
- 53885-64-6
- MF:
- C14H11Cl2NS
- Structure:
- Chemical Name:
- ClarithroMycin 9-OxiMe
- CAS:
- 103450-87-9
- MF:
- C38H70N2O13
- Structure:
- Chemical Name:
- Desloratadine N-Hydroxypiperidine
- CAS:
- 1193725-73-3
- MF:
- C19H19ClN2O
- Structure:
- Chemical Name:
- O-DesMethyl Venlafaxine Cyclic IMpurity
- CAS:
- 1346601-55-5
- MF:
- C16H23NO2
- Structure:
- Chemical Name:
- rac-cis-2,3-Dichloro Sertraline Hydrochloride
- CAS:
- 1198084-29-5
- MF:
- C17H18Cl3N
- Structure:
- Chemical Name:
- 11β-Hydroperoxy Dienogest
- CAS:
- 106111-43-7
- MF:
- C20H25NO4
- Structure:
- Chemical Name:
- 2'-Nor ThiaMine
- CAS:
- 7770-93-6
- MF:
- C11H15ClN4OS
- Structure:
- Chemical Name:
- 6α-Methyl Hydrocortisone 21-Acetate
- CAS:
- 1625-11-2
- MF:
- C24H34O6
- Structure:
- Chemical Name:
- N1-Losartanyl-losartan (Losartan IMpurity)
- CAS:
- 230971-71-8
- MF:
- C44H44Cl2N12O
- Structure:
- Chemical Name:
- N2-Losartanyl-losartan (Losartan IMpurity)
- CAS:
- 230971-72-9
- MF:
- C44H44Cl2N12O
- Structure:
- Chemical Name:
- N-Ethoxycarbonyl 7-ADCA
- CAS:
- 72820-16-7
- MF:
- C11H14N2O5S
- Structure:
- Chemical Name:
- 4-PyridinecarboxaMide, N-(2,6-diMethylphenyl)-
- CAS:
- 68280-05-7
- MF:
- C14H14N2O
- Structure:
- Chemical Name:
- 4-N-Desacetyl-5-N-acetyl OseltaMivir
- CAS:
- 956267-10-0
- MF:
- C16H28N2O4
- Structure:
- Chemical Name:
- rac N-DesMethyl-N-(4-Methoxyphenethyl) Venlafaxine
- CAS:
- 1346601-14-6
- MF:
- C25H35NO3
- Structure:
- Chemical Name:
- 11-Keto Oxcarbazepine
- CAS:
- 537693-29-1
- MF:
- C15H10N2O3
- Structure:
- Chemical Name:
- Isopropyl 4-(3-AMinophenyl)-1,4-dihydro-5-(2-Methoxyethoxycarbonyl)-2,6-diMethylpyridine-3-carboxylate
- CAS:
- 155861-24-8
- MF:
- C21H28N2O5
- Structure:
- Chemical Name:
- (E)-Olopatadine
- CAS:
- 113806-06-7
- MF:
- C21H23NO3
- Structure:
- Chemical Name:
- NeMadipine B
- CAS:
- 79925-38-5
- MF:
- C19H21Cl2NO4
- Structure:
- Chemical Name:
- N-[(3,4-DiMethoxy-2-pyridinyl)Methyl] Pantoprazole
- CAS:
- 957470-59-6
- MF:
- C24H24F2N4O6S
- Structure:
- Chemical Name:
- 4-Epi-6-epi Doxycycline
- CAS:
- 97583-08-9
- MF:
- C22H24N2O8
- Structure:
- Chemical Name:
- Sertraline-d3 hydrochloride
- MF:
- C17H15Cl3D3N
- Chemical Name:
- piperacillinylaMpicillin
- Chemical Name:
- Celecoxib iMpurity-B
- Chemical Name:
- EMtricitabine iMpurity B
- Structure:
- Chemical Name:
- (S,S)-1,7-diazatricyclo[7.3.0.07,11]dodecane-2,6,8,12-tetrone
- CAS:
- 14842-41-2
- MF:
- C10H10N2O4
- Structure:
- Chemical Name:
- 1-Hydroxy-7-Methoxy-1,2,3,4-tetrahydronaphthalene
- CAS:
- 32820-10-3
- MF:
- C11H14O2
- Structure:
- Chemical Name:
- BroMhexine Hydrochloride iMpurity DN-(2-AMino-5-broMobenzyl)-N-MethylcyclohexanaMine Dihydrochloride
- CAS:
- 132004-28-5
- MF:
- C14H21BrN2
- Structure:
- Chemical Name:
- 2-(DiMethylcarbaMoyl)benzoic acid, 97%
- CAS:
- 20320-37-0
- MF:
- C10H11NO3
- Structure:
- Chemical Name:
- RAC DESMETHYL CITALOPRAM HYDROCHLORIDE
- CAS:
- 97743-99-2
- MF:
- C19H19FN2O
- Structure:
- Chemical Name:
- rac-3-Oxo Atorvastatin SodiuM Salt
- CAS:
- 1391052-00-8
- MF:
- C33H34FN2NaO5
- Structure:
- Chemical Name:
- 2-Demethoxy-4-methoxy urapidil
- CAS:
- 34661-79-5
- MF:
- C20H29N5O3
- Structure:
- Chemical Name:
- Ribavirin IMpurity F
- CAS:
- 58151-87-4
- MF:
- C10H14N4O6
- Structure:
- Chemical Name:
- 4-[-((-((4-(5-(Bis(2-hydroxyethyl)aMino)-1-Methyl-1H-benzo[d]iMidazol-2-yl)butanoyl)oxy)ethyl)(2-hydroxyethyl)aMino)-1-Methyl-1H-benzo[d]iMidazol-2-yl)butanic Acid
- CAS:
- 1228551-91-4
- MF:
- C32H41Cl3N6O4
- Structure:
- Chemical Name:
- 3-(6,7-Dihydro-2-Methyl-7-oxo-3-propyl-2H-pyrazolo[4,3-d]pyriMidin-5-yl)-4-ethoxy-benzenesulfonyl Chloride
- CAS:
- 501120-42-9
- MF:
- C17H19ClN4O4S
- Structure:
- Chemical Name:
- (3R,4S)-rel-3-[(1,3-Benzodioxol-5-yloxy)Methyl]-4-(4'-fluoro[1,1'-biphenyl]-4-yl)-piperidine Hydrochloride
- CAS:
- 1217655-87-2
- MF:
- C25H25ClFNO3
- Structure:
- Chemical Name:
- Sitagliptin Defuoro IMpurity 4
- CAS:
- 486459-98-7
- MF:
- C15H19F2NO4
- Chemical Name:
- Sulpiride IMpurity F
- Structure:
- Chemical Name:
- trans-Ibuprofen IMpurity G
- CAS:
- 1391054-15-1
- MF:
- C26H32O4
- Structure:
- Chemical Name:
- EthanediaMide iMpurity F
- CAS:
- 480452-37-7
- MF:
- C16H22ClN5O3