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:
- 5-Bromo-1-(4-fluorophenyl)-1,3-dihydro-N,N-dimethyl-1-isobenzofuranpropanamine ethanedioate (1:1)
- CAS:
- 64372-43-6
- MF:
- C21H23BrFNO5
- Structure:
- Chemical Name:
- (E)-2-Methyl-4-(4-(2-Methyl-5,10-dihydro-4H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-yl)-10H-benzo[b]thieno[2,3-e][1,4]diazepine
- CAS:
- 1070876-09-3
- MF:
- C28H26N6S2
- Structure:
- Chemical Name:
- Posaconazole DiastereoisoMer interMediate 5
- CAS:
- 149809-42-7
- MF:
- C21H21F2N3O4S
- Structure:
- Chemical Name:
- Prasugrel alpha-Hydroxy IMpurity
- CAS:
- 1100905-45-0
- MF:
- C11H11FO2
- Structure:
- Chemical Name:
- Solifenacin Related CoMpound 2 Succinate
- CAS:
- 1262506-09-1
- MF:
- C27H32N2O6
- Structure:
- Chemical Name:
- Tetrahydro FuroseMide
- CAS:
- 4793-38-8
- MF:
- C12H15ClN2O5S
- Structure:
- Chemical Name:
- 6-O-DesMethoxyethyl-6-O-chloroethyl Erlotinib Hydrochloride
- CAS:
- 183320-04-9
- MF:
- C21H21Cl2N3O3
- Structure:
- Chemical Name:
- LincoMycin 2-Phosphate
- CAS:
- 27480-30-4
- MF:
- C18H35N2O9PS
- Structure:
- Chemical Name:
- Macitentan IMpurity
- CAS:
- 556796-88-4
- MF:
- C17H15Br2N5O4S
- Structure:
- Chemical Name:
- 4-((4-broMophenyl)(1H-1,2,4-triazol-1-yl)Methyl)benzonitrile
- CAS:
- 143030-54-0
- MF:
- C16H11BrN4
- Structure:
- Chemical Name:
- Acetic acid, 2-[2-[4-(diphenylMethyl)-1-piperazinyl]ethoxy]-
- CAS:
- 83881-53-2
- MF:
- C21H26N2O3
- Structure:
- Chemical Name:
- AlMotriptan Related CoMpound B
- CAS:
- 1246860-65-0
- MF:
- C19H25N3O6S
- Chemical Name:
- Benazepril Related CoMpound B
- Structure:
- Chemical Name:
- IMatinib iMpurity
- CAS:
- 152459-96-6
- MF:
- C24H21N5O
- Structure:
- Chemical Name:
- (2R,3R,4R,5S,6R)-2-(acetoxyMethyl)-6-(3-((5-(4-fluorophenyl)thiophen-2-yl)Methyl)-4-Methylphenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate
- MF:
- C32H33FO9S
- Structure:
- Chemical Name:
- 1,2-BenzenedicarboxaMide, N1,N2-bis[[(5S)-2-oxo-3-[4-(3-oxo-4-Morpholinyl)phenyl]-5-oxazolidinyl]Methyl]-
- CAS:
- 1365267-36-2
- MF:
- C36H36N6O10
- Structure:
- Chemical Name:
- 2-QuinazolineMethanol, 4-Methyl-
- CAS:
- 13535-91-6
- MF:
- C10H10N2O
- Structure:
- Chemical Name:
- 5-(2,2-diMethyl-4H-benzo[d][1,3]dioxin-6-yl)oxazolidin-2-one
- CAS:
- 452340-96-4
- MF:
- C13H15NO4
- Chemical Name:
- Entacapone
- Structure:
- Chemical Name:
- nifedipine iMpurity
- MF:
- C19H22N2O6
- Chemical Name:
- Linagliptin Impurity A
- Structure:
- Chemical Name:
- Dehydropitavastatin ethyl ester
- CAS:
- 254452-91-0
- MF:
- C27H26FNO4
- Structure:
- Chemical Name:
- (S)-2-(2-oxo-4-propyl-2,5-dihydro-1H-pyrrol-1-yl)butanamide
- CAS:
- 357338-13-7
- MF:
- C11H18N2O2
- Chemical Name:
- Linagliptin Impurity V
- Structure:
- Chemical Name:
- methyl 2-(4-(2-chloroethyl)phenyl)-2-methylpropanoate
- CAS:
- 1181267-33-3
- MF:
- C13H17ClO2
- Structure:
- Chemical Name:
- (2RS)-1-bromo-2-(2,4-difluorophenyl)-3-(1H-1,2,4-triazol-1-yl)propan-2-ol
- CAS:
- 150194-52-8
- MF:
- C11H10BrF2N3O
- Structure:
- Chemical Name:
- (S)-2-(((1R,2S,5S)-2-(2-((5-chloropyridin-2-yl)amino)-2-oxoacetamido)-5-(dimethylcarbamoyl)cyclohexyl)carbamoyl)-5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine 5-oxide
- MF:
- C24H30ClN7O5S
- Chemical Name:
- Etoricoxib Impurity 18
- Structure:
- Chemical Name:
- Ibrutinib Impurity 4
- CAS:
- 1807619-68-6
- MF:
- C17H12ClN5O
- Chemical Name:
- Imatinib Impurity 3
- Chemical Name:
- Mirabegron Impurity 16
- Chemical Name:
- Olaparib Impurity 2
- Structure:
- Chemical Name:
- Sofosbuvir Impurity 7
- CAS:
- 1884385-12-9
- MF:
- C20H19FO6
- Structure:
- Chemical Name:
- Vonoprazan Impurity 3
- CAS:
- 928325-41-1
- MF:
- C17H15F2N3O2S
- Chemical Name:
- Cinacalcet Impurity 22
- Chemical Name:
- Dapagliflozin Impurity C
- Chemical Name:
- Dasatinib Impurity E
- Chemical Name:
- Ixazomib Impurity
- Chemical Name:
- Nevirapine Impurity
- Structure:
- Chemical Name:
- Omarigliptin Impurity
- CAS:
- 1819364-01-6
- MF:
- C16H18F2N4O
- Structure:
- Chemical Name:
- Palbociclib Impurity 8
- CAS:
- 827022-31-1
- MF:
- C31H41N7O4
- Structure:
- Chemical Name:
- Sitagliptin EP Impurity C
- CAS:
- 1345822-86-7
- MF:
- C16H19F5N5O5P
- Chemical Name:
- Trifluridine Impurity
- CAS:
- 2086328-10-9
- Chemical Name:
- Valsartan related compound H
- Structure:
- Chemical Name:
- Vildagliptin Related Compound H
- CAS:
- 2253194-13-5
- MF:
- C12H16N4O
- Chemical Name:
- Moxifloxacin Impurity 7
- Structure:
- Chemical Name:
- (R)-6-Benzyloxy-8-(oxiran-2-yl)-4H-benzo[1,4]oxazin-3-one
- CAS:
- 869478-12-6
- MF:
- C17H15NO4
- Structure:
- Chemical Name:
- Merariveron impurity D
- MF:
- C26H28N6O3S2
- Chemical Name:
- Cefazolin impurity E
- Chemical Name:
- Lamivudine Impurity Mixture
- Structure:
- Chemical Name:
- Rifaximin impurity B
- CAS:
- 1351775-04-6
- MF:
- C43H49N3O11
- Structure:
- Chemical Name:
- 4-(3-(Piperidin-1-yl)propoxy)benzoic acid
- CAS:
- 767286-87-3
- MF:
- C15H21NO3
- Structure:
- Chemical Name:
- 5-Chloro-3-sulfino-2-thiophenecarboxylic acid
- CAS:
- 187746-97-0
- MF:
- C5H3ClO4S2
- Structure:
- Chemical Name:
- ethyl (S)-10-fluoro-3-methyl-7-oxo- 2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylate
- CAS:
- 431058-46-7
- MF:
- C15H14FNO4
- Structure:
- Chemical Name:
- methyl (Z)-3-(((4-(methylamino)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate
- MF:
- C24H21N3O3
- Structure:
- Chemical Name:
- Isavuconazole Impurity 11
- CAS:
- 2732924-99-9
- MF:
- C10H16ClN3O2
- Structure:
- Chemical Name:
- Levosimendan Impurity 2
- CAS:
- 103416-88-2
- MF:
- C11H12N2O2
- Structure:
- Chemical Name:
- Aprepitant EP Impurity B
- CAS:
- 2206606-86-0
- MF:
- C29H25F7N4O3
- Structure:
- Chemical Name:
- Famotidine EP Impurity A
- CAS:
- 88061-72-7
- MF:
- C8H15N7O2S3
- Structure:
- Chemical Name:
- Meloxicam EP Impurity D
- CAS:
- 1331636-17-9
- MF:
- C16H17N3O4S2
- Structure:
- Chemical Name:
- Erythromycin Impurity
- CAS:
- 40554-78-7
- MF:
- C37H65NO12
- Structure:
- Chemical Name:
- Fluconazole EP Impurity I
- CAS:
- 150168-54-0
- MF:
- C13H14BrF2N7O
- Structure:
- Chemical Name:
- 1-benzyl-2-methyl-1H-imidazole-carbaldehyde
- CAS:
- 39269-74-4
- MF:
- C12H12N2O
- Structure:
- Chemical Name:
- Sacubitril Impurity
- CAS:
- 1015037-46-3
- MF:
- C23H27NO4
- Structure:
- Chemical Name:
- Desloratadine Impurity
- CAS:
- 50603-12-8
- MF:
- C20H21N
- Chemical Name:
- Olaparib Impurity H
- Chemical Name:
- Brexpiprazole Impurity B
- Chemical Name:
- Dapoxetine iMpurity 6
- Structure:
- Chemical Name:
- Irbesartan Impurity 4
- MF:
- C25H28N6O
- Structure:
- Chemical Name:
- 2-cyclopentylidene-2-phenylacetic acid
- MF:
- C13H14O2
- Chemical Name:
- Cabozantinib impurity B
- Structure:
- Chemical Name:
- Metoprolol IMpurity 3
- MF:
- C15H25NO3
- Chemical Name:
- Mirabegron Impurity 1
- Structure:
- Chemical Name:
- Desfluoro Pitavastatin Calcium
- CAS:
- 847849-67-6
- MF:
- C25H25NO4
- Structure:
- Chemical Name:
- Plerixafor
- CAS:
- 548488-49-9
- MF:
- C12H23F3N4O
- Chemical Name:
- Vonoprazan Impurity 10
- Chemical Name:
- Vonoprazan Impurity 5
- Chemical Name:
- Sitagliptin IMpurity 1
- Chemical Name:
- Etoricoxib Impurity 7
- Chemical Name:
- Ezetimibe Impurity D
- Chemical Name:
- Alogliptin Imp.13
- Chemical Name:
- Erlotinib Imp.18
- Structure:
- Chemical Name:
- Ezetimibe (RSS)-Isomer
- CAS:
- 1478664-18-4
- MF:
- C24H21F2NO3
- Chemical Name:
- Apremilast Impurity 6
- Structure:
- Chemical Name:
- Azilsartan Impurity 16
- CAS:
- 1417576-00-1
- MF:
- C28H20N4O8
- Structure:
- Chemical Name:
- Regorafenib Impurity 11
- CAS:
- 2512204-88-3
- MF:
- C19H18ClFN4O3
- Structure:
- Chemical Name:
- Topiroxostat Impurity 2
- CAS:
- 445218-61-1
- MF:
- C12H11N5O
- Structure:
- Chemical Name:
- Fluvastatin Impurity 1
- MF:
- C24H26FNO4
- Chemical Name:
- Lornoxicam Impurity 7
- Structure:
- Chemical Name:
- Prednisolone Impurity A
- MF:
- C21H28O5
- Structure:
- Chemical Name:
- Tofacitinib Impurity 6
- CAS:
- 1640972-35-5
- MF:
- C16H22N6O
- Chemical Name:
- Afatinib Impurity 20
- Structure:
- Chemical Name:
- 1-(4-Ethylphenyl)-2-methyl-2-propen-1-one
- CAS:
- 70639-76-8
- MF:
- C12H14O
- Chemical Name:
- Ceftriaxone Sodium impurity
- Chemical Name:
- Clarithromycin impurity
- Structure:
- Chemical Name:
- Ivabradine Impurity 5
- CAS:
- 1462470-54-7
- MF:
- C27H38N2O6
- Structure:
- Chemical Name:
- Aprepitant Impurity 6
- CAS:
- 170902-81-5
- MF:
- C23H21F7N4O3
- Structure:
- Chemical Name:
- (S)-3-((R)-5-(4-fluorophenyl)-5-hydroxy-2-((E)-4-hydroxybenzylidene)pentanoyl)-4-phenyloxazolidin-2-one
- MF:
- C27H24FNO5
- Structure:
- Chemical Name:
- Alogliptin Related Compound 14
- CAS:
- 1820685-30-0
- MF:
- C18H23N5O3
- Structure:
- Chemical Name:
- (3S,5S)-Atorvastatin (sodium salt)
- CAS:
- 1428118-38-0
- MF:
- C33H36FN2NaO5