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:
- Rac Atomoxetine Hydrochloride
- CAS:
- 82857-40-7
- MF:
- C17H22ClNO
- Structure:
- Chemical Name:
- 3-(1H-imidazol-1-yl)-5-(trifluoromethyl)aniline
- CAS:
- 943320-48-7
- MF:
- C10H8F3N3
- Structure:
- Chemical Name:
- Linagliptin Impurity H
- CAS:
- 1646355-34-1
- MF:
- C22H23N7O2
- Structure:
- Chemical Name:
- Ezetimibe Impurity 54
- CAS:
- 1185883-39-9
- MF:
- C40H36F2N2O5
- Structure:
- Chemical Name:
- 2-(2-fluorophenyl)-1,3-di(1H-1,2,4-triazol-1-yl)propan-2-ol
- CAS:
- 1348664-75-4
- MF:
- C13H13FN6O
- Chemical Name:
- Dapagliflozin Impurity 2
- Chemical Name:
- Imatinib Impurity 1
- Chemical Name:
- Imatinib Impurity 6
- Structure:
- Chemical Name:
- Nifedipine Impurity 3
- MF:
- C19H22N2O6
- Chemical Name:
- Riociguat Impurtiy 5
- Chemical Name:
- Vonoprazan Impurity 6
- Structure:
- Chemical Name:
- Avibactam Impurity
- CAS:
- 1797133-98-2
- MF:
- C7H12N3NaO6S
- Structure:
- Chemical Name:
- Citalopram EP Impurity E
- CAS:
- 64169-47-7
- MF:
- C19H22Cl2FNO
- Chemical Name:
- Dapagliflozin Impurity F
- Chemical Name:
- Dapoxetine Impurity A
- Structure:
- Chemical Name:
- Entecavir Impurity
- CAS:
- 1333204-94-6
- MF:
- C12H15N5O3
- Chemical Name:
- Gadobutrol Impurity
- Chemical Name:
- Lesinurad Impurity
- Structure:
- Chemical Name:
- Ozagrel methylester
- CAS:
- 866157-50-8
- MF:
- C13H12N2O2
- Structure:
- Chemical Name:
- 2-Propanol, 1-[2-(2-methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]-
- CAS:
- 163685-38-9
- MF:
- C15H25NO3
- Structure:
- Chemical Name:
- Ribavirin Related Compound A (15 mg) (1-beta-D-ribofuranosyl-1H-1,2,4-triazole-3-carboxylic acid)
- CAS:
- 39925-19-4
- MF:
- C8H11N3O6
- Structure:
- Chemical Name:
- (1R,2R)-2-(3,4-difluorophenyl)cyclopropanecarboxylic acid
- CAS:
- 220352-36-3
- MF:
- C10H8F2O2
- Structure:
- Chemical Name:
- (2S,4S)-4-[4-(3-Methyl-1-phenyl-1H-pyrazol-5-yl)-1-piperazinyl]-2-(3-thiazolidinylcarbonyl)-1-pyrrolidinecarboxylic acid tert-butyl ester
- CAS:
- 401566-80-1
- MF:
- C27H38N6O3S
- Structure:
- Chemical Name:
- trans-4,5-Dichloro-4,5-diMethyl-1,3-dioxolan-2-one
- CAS:
- 116857-05-7
- MF:
- C5H6Cl2O3
- Structure:
- Chemical Name:
- 4-Methoxy-5-(3-Morpholinopropoxy)-2-nitrobenzaMide
- CAS:
- 861453-16-9
- MF:
- C15H21N3O6
- Structure:
- Chemical Name:
- 5-chloro-3-sulfo-2-Thiophenecarboxylic acid
- CAS:
- 187746-94-7
- MF:
- C5H3ClO5S2
- Structure:
- Chemical Name:
- 2,2'-(4,4'-(3,3'-(isopropylazanediyl)bis(2-hydroxypropane-3,1-diyl))bis(oxy)bis(4,1-phenylene))diacetaMide
- CAS:
- 87619-83-8
- MF:
- C25H35N3O6
- Structure:
- Chemical Name:
- 5-Methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxylic acid hydrochloride
- CAS:
- 720720-96-7
- MF:
- C8H11ClN2O2S
- Structure:
- Chemical Name:
- 3,3'-diMethyl-1,1'-diphenyl-1H,1'H-4,4'-bipyrazole-5,5'-diol
- CAS:
- 177415-76-8
- MF:
- C20H18N4O2
- Structure:
- Chemical Name:
- 5-(2-cyclopropyl-1-(3-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate
- CAS:
- 1391194-39-0
- MF:
- C20H20FNO3S
- Structure:
- Chemical Name:
- (S)-N-(1-(3-MethylbutanaMido)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide
- CAS:
- 862894-96-0
- MF:
- C19H22N4O3
- Structure:
- Chemical Name:
- Ticagrelor iMpurity
- CAS:
- 1882095-51-3
- MF:
- C27H45N5O8S
- Structure:
- Chemical Name:
- cefaclor iMpurity G
- CAS:
- 67308-21-8
- MF:
- C16H17N3O4S
- Chemical Name:
- Rupatadine iMpurity E
- Structure:
- Chemical Name:
- Tadalafil iMpurity D
- CAS:
- 951661-81-7
- MF:
- C22H20ClN3O4
- Structure:
- Chemical Name:
- 2-Thiopheneacetic acid, α-hydroxy-α-2-thienyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester
- CAS:
- 320347-97-5
- MF:
- C17H19NO3S2
- Chemical Name:
- benzbroMarone iMpurity
- Structure:
- Chemical Name:
- Dasatinib iMpurity
- CAS:
- 1184919-23-0
- MF:
- C22H27N7O2S
- Chemical Name:
- eszopiclone iMpurity
- Structure:
- Chemical Name:
- IMidafenacin iMpurity
- CAS:
- 503599-41-5
- MF:
- C18H20N2O2
- Structure:
- Chemical Name:
- latanoprost iMpurity
- CAS:
- 733036-95-8
- MF:
- C25H35FO5
- Structure:
- Chemical Name:
- Irbesartan IMpurity D
- MF:
- C25H28N6O
- Structure:
- Chemical Name:
- Ondansetron HCl IMpurity-G
- CAS:
- 99614-03-6
- MF:
- C17H17N3O
- Structure:
- Chemical Name:
- lithiuM 2-(4-(Methylsulfonyl)phenyl)acetate
- CAS:
- 1421227-96-4
- MF:
- C9H11LiO4S
- Structure:
- Chemical Name:
- Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetaMide)
- CAS:
- 120512-03-0
- MF:
- C17H21N5O
- Chemical Name:
- ApreMilast IMpurity
- Structure:
- Chemical Name:
- 5'-broMo-[2,3'-bipyridin]-6'(1'H)-one
- CAS:
- 381233-79-0
- MF:
- C10H7BrN2O
- Chemical Name:
- Pramipexole Impurity G
- Structure:
- Chemical Name:
- Salmeterol EP Impurity A
- CAS:
- 1798014-51-3
- MF:
- C19H25NO3
- Chemical Name:
- Tacrolimus impurity D
- Structure:
- Chemical Name:
- 2-(2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)propan-2-yl)-4,4-dimethyl-4,5-dihydrooxazole
- CAS:
- 202189-77-3
- MF:
- C32H44N4O2
- Chemical Name:
- Saxagliptin Impurity 6
- Structure:
- Chemical Name:
- Alcaftadine N-Oxide
- CAS:
- 952649-75-1
- MF:
- C19H21N3O2
- Structure:
- Chemical Name:
- (R)-De(trifluoromethyl) Fluoxetine Hydrochloride
- CAS:
- 1212215-97-8
- MF:
- C16H20ClNO
- Structure:
- Chemical Name:
- CLOZAPINE-D3
- CAS:
- 1215691-72-7
- MF:
- C18H19ClN4
- Chemical Name:
- Bendamustine Impurity 25
- Chemical Name:
- Canagliflozin Impurity 25
- Structure:
- Chemical Name:
- Edoxaban Impurity 41
- CAS:
- 1353893-25-0
- MF:
- C14H27N3O3
- Chemical Name:
- Istradefylline Impurity 5
- Chemical Name:
- Milrinone Impurity 10
- Structure:
- Chemical Name:
- N-(2-Chloro-ethyl)-N'-(2,3-dichloro-phenyl)-ethane-1,2-diamine
- MF:
- C10H13Cl3N2
- Structure:
- Chemical Name:
- Olanzapine Impurity 3
- MF:
- C17H20N4S
- Chemical Name:
- Ticagrelor Related Compound 54
- Chemical Name:
- Adefovir Impurity D
- Chemical Name:
- Blonanserin Impurity N
- Chemical Name:
- Brexpiprazole Impurity N
- Chemical Name:
- Cefaclor Impurity 1
- Chemical Name:
- Cefminox Sodium impurity 4
- Chemical Name:
- Cefradine Impurity B
- Chemical Name:
- Dapoxetine Impurity F
- Chemical Name:
- Olaparib Impurity E
- Structure:
- Chemical Name:
- Levofloxacin Impurity 23
- CAS:
- 2206825-95-6
- MF:
- C19H21ClFN3O4
- Structure:
- Chemical Name:
- Nitrendipine impurity 1
- CAS:
- 1242511-98-3
- MF:
- C18H18N2O5
- Structure:
- Chemical Name:
- methyl 7-bromo-4-hydroxyisoquinoline-3-carboxylate
- CAS:
- 1572439-66-7
- MF:
- C11H8BrNO3
- Structure:
- Chemical Name:
- Dapoxetine impurity
- CAS:
- 2242008-36-0
- MF:
- C28H26O3
- Structure:
- Chemical Name:
- Pregabalin Impurity 11
- CAS:
- 177432-20-1
- MF:
- C7H11NO3
- Structure:
- Chemical Name:
- Pregabalin Impurity 6
- CAS:
- 2102350-92-3
- MF:
- C9H15NO3
- Chemical Name:
- Sunitinib Impurity 2
- Structure:
- Chemical Name:
- (2S,3R,4R,5S,6R)-2-(3-(4-ethoxybenzyl)phenyl)-6-(hydroxyl methyl)tetrahydro-2H-pyran-3,4,5-triol
- CAS:
- 2452300-89-7
- MF:
- C21H26O6
- Structure:
- Chemical Name:
- (R)-Zanubrutinib
- CAS:
- 1691249-44-1
- MF:
- C27H29N5O3
- Structure:
- Chemical Name:
- LUMAT-005
- CAS:
- 313369-16-3
- MF:
- C16H19N3O3
- Chemical Name:
- Fimasartan Impurity F
- Structure:
- Chemical Name:
- 1-((2R,3R)-2-(benzyloxy)pentan-3-yl)-4-(4-(4-(4-hydroxyphenyl)piperazin-1-yl)phenyl)-1H-1,2,4-triazol-5(4H)-one
- CAS:
- 2243786-01-6
- MF:
- C30H35N5O3
- Structure:
- Chemical Name:
- 5-(3-fluorophenyl)-1H-pyrrole-3-carbaldehyde
- MF:
- C11H8FNO
- Structure:
- Chemical Name:
- 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid bis(1-methylethyl) ester
- CAS:
- 21881-78-7
- MF:
- C21H26N2O6
- Structure:
- Chemical Name:
- 2-(4-Methylphenyl)sulfonyloxyethanol
- CAS:
- 42772-85-0
- MF:
- C9H12O4S
- Structure:
- Chemical Name:
- 2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2S)-2-aMino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-, (1R,3R,5R)-
- CAS:
- 1564265-94-6
- MF:
- C18H25N3O2
- Structure:
- Chemical Name:
- (-)-Syringaresinol-4-O-beta-D-glucopyranoside
- CAS:
- 137038-13-2
- MF:
- C28H36O13
- Structure:
- Chemical Name:
- Budesonide Impurity (1, 4-Androstadien-11-beta-16-alfa-diol-3, 17-dione)
- CAS:
- 910299-74-0
- MF:
- C19H24O4
- Structure:
- Chemical Name:
- Etoricoxib Impurity 12
- CAS:
- 646459-41-8
- MF:
- C21H16ClN3O2S
- Structure:
- Chemical Name:
- Levofloxacin Tetrafluoro Impurity 2
- CAS:
- 103995-33-1
- MF:
- C14H12F4O4
- Structure:
- Chemical Name:
- Mupirocin Impurity C
- MF:
- C26H44O9
- Structure:
- Chemical Name:
- Verapamil Impurity H
- CAS:
- 67018-83-1
- MF:
- C26H36N2O4
- Structure:
- Chemical Name:
- Warfarin Impurity 1
- CAS:
- 55901-61-6
- MF:
- C13H14O
- Structure:
- Chemical Name:
- Vitexin -4''-O-glucoside
- CAS:
- 178468-00-3
- MF:
- C27H30O15
- Chemical Name:
- Aripiprazole EP impurity D
- Structure:
- Chemical Name:
- Macitentan impurity B
- CAS:
- 441796-13-0
- MF:
- C18H18Br2N6O4S
- Chemical Name:
- Meropenem IMP B
- Structure:
- Chemical Name:
- tert-butyl 4-(6-bromopyridin-3-yl)piperazine-1-carboxylate
- CAS:
- 412348-27-7
- MF:
- C14H20BrN3O2