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:
- 2,2'-(oxybis((2-chloro-5-iodophenyl)methylene))diphenol
- MF:
- C26H18Cl2I2O3
- Structure:
- Chemical Name:
- Gliclazide Impurity 6
- CAS:
- 1207714-41-7
- MF:
- C8H10N2O3S
- Structure:
- Chemical Name:
- Phenol, 4,4'-(4-pyridinylmethylene)bis-
- CAS:
- 109810-81-3
- MF:
- C18H15NO2
- Chemical Name:
- Ropivacaine Impurity 50
- Chemical Name:
- Butyphthalide impurity 53
- Structure:
- Chemical Name:
- 4-(DICHLOROMETHYL)BENZONITRILE
- CAS:
- 74231-65-5
- MF:
- C8H5Cl2N
- Structure:
- Chemical Name:
- 4-(DICHLOROMETHYL)BENZONITRILE
- CAS:
- 74231-65-5
- MF:
- C8H5Cl2N
- Structure:
- Chemical Name:
- 4-(DICHLOROMETHYL)BENZONITRILE
- CAS:
- 74231-65-5
- MF:
- C8H5Cl2N
- Structure:
- Chemical Name:
- 3-(4-FLUORO-PHENYL)-1-ISOPROPYL-1H-INDOLE-2-CARBALDEHYDE
- CAS:
- 101125-34-2
- MF:
- C18H16FNO
- Structure:
- Chemical Name:
- 3,4-DIMETHOXY-2-HYDROXYBENZALDEHYDE
- CAS:
- 19283-70-6
- MF:
- C9H10O4
- Chemical Name:
- Tazobactam Impurity EBT
- Chemical Name:
- Mixture of Cefoxitin Impurities E&F
- Chemical Name:
- Faropenem Degradation Impurity 4
- Structure:
- Chemical Name:
- Oxacillin Impurity 3
- CAS:
- 21106-64-9
- MF:
- C19H18ClN3O5S
- Structure:
- Chemical Name:
- Latanoprost Impurity 3
- CAS:
- 2278245-92-2
- MF:
- C27H41BrO5
- Structure:
- Chemical Name:
- Ethyl 2-(2-Iodoethoxy)acetate
- CAS:
- 56703-25-4
- MF:
- C6H11IO3
- Structure:
- Chemical Name:
- 6,8-DIBROMO-3-CYCLOHEXYL-3,4-DIHYDRO-2(1H)-QUINAZOLINONE
- CAS:
- 21237-84-3
- MF:
- C14H16Br2N2O
- Structure:
- Chemical Name:
- DESTHIAZOLYLMETHYL RITONAVIR
- CAS:
- 256328-82-2
- MF:
- C33H43N5O4S
- Structure:
- Chemical Name:
- S-DIDEMETHYL CITALOPRAM
- CAS:
- 166037-78-1
- MF:
- C18H17FN2O
- Structure:
- Chemical Name:
- METHOTREXATE DIMETHYL ESTER
- CAS:
- 34378-65-9
- MF:
- C22H26N8O5
- Chemical Name:
- (Z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)-3-methylbutanoic acid
- Chemical Name:
- (Z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)-3-methylbutanoic acid
- Structure:
- Chemical Name:
- (9S)-9-Amino-9-deoxoerythromycin
- CAS:
- 26116-56-3
- MF:
- C37H70N2O12
- Chemical Name:
- Oseltamivir Impurity 124
- Chemical Name:
- Oseltamivir Impurity 114
- Chemical Name:
- Avatrombopag Impurity 69
- Structure:
- Chemical Name:
- (1R,3aS,4E,7aR)-4-[(2E)-2-[(3S,5R)-3,5-bis[[(1,1-dimethylethyl)dimethylsilyl]oxy]-2-methylenecyclohexylidene]ethylidene]octahydro-7a-methyl-1-[(1R,4S)-1,4,5-trimethylhexyl]-1H-Indene
- CAS:
- 2229745-37-1
- MF:
- C40H74O2Si2
- Structure:
- Chemical Name:
- (+)-Tamsulosin
- CAS:
- 106138-88-9
- MF:
- C20H28N2O5S
- Structure:
- Chemical Name:
- 2-Pyrrolidinecarboxamide,1-(hydroxyacetyl)-,(S)-(9CI)
- CAS:
- 96166-39-1
- MF:
- C7H12N2O3
- Structure:
- Chemical Name:
- 1H-Pyrazole,3-ethoxy-5-methyl-1-phenyl-(9CI)
- CAS:
- 300543-31-1
- MF:
- C12H14N2O
- Structure:
- Chemical Name:
- apiopaeonoside
- CAS:
- 100291-86-9
- MF:
- C20H28O12
- Structure:
- Chemical Name:
- (2-PHENOXY)METHYLSULFONYLANILINE
- CAS:
- 51765-51-6
- MF:
- C13H13NO3S
- Chemical Name:
- (S)-Cilastatin EP Impurity G
- Structure:
- Chemical Name:
- 4-methoxy-2,3,5-trimethylpyridine
- CAS:
- 109371-19-9
- MF:
- C9H13NO
- Structure:
- Chemical Name:
- Lexithromycin
- CAS:
- 53066-26-5
- MF:
- C38H70N2O13
- Chemical Name:
- Imimidistine impurity B
- Structure:
- Chemical Name:
- methylprednisolone 17-hemisuccinate
- CAS:
- 77074-42-1
- MF:
- C26H34O8
- Chemical Name:
- 8-hydroxymethylriboflavin
- CAS:
- 52134-62-0
- MF:
- C17H20N4O7
- Structure:
- Chemical Name:
- RS 42358-197
- CAS:
- 135729-55-4
- MF:
- C19H23ClN2O
- Structure:
- Chemical Name:
- acetylthiamine
- CAS:
- 3419-28-1
- Structure:
- Chemical Name:
- deacetylcephalosporin C
- CAS:
- 1476-46-6
- MF:
- C14H19N3O7S
- Structure:
- Chemical Name:
- N-nitroso-N-methylcyclohexylamine
- CAS:
- 5432-28-0
- MF:
- C7H14N2O
- Structure:
- Chemical Name:
- ETHYLVANILLINBETA-D-GLUCOPYRANOSIDE
- CAS:
- 122397-96-0
- MF:
- C15H20O8
- Structure:
- Chemical Name:
- 4-(2-Cyanophenyl)benzyl alcohol
- CAS:
- 154709-19-0
- MF:
- C14H11NO
- Structure:
- Chemical Name:
- 1-Propanol, 3-[[2-[(1H-benzimidazol-2-ylsulfinyl)methyl]-3-methyl-4-pyridinyl]oxy]-
- CAS:
- 117976-94-0
- MF:
- C17H19N3O3S
- Structure:
- Chemical Name:
- 2',3'-O-isopropylidene cytidine
- CAS:
- 362-42-5
- MF:
- C12H17N3O5
- Structure:
- Chemical Name:
- 4,4''-Dimethoxyazoxybenzene
- CAS:
- 501-58-6
- MF:
- C14H14N2O2
- Structure:
- Chemical Name:
- 3,5-Dibenzyloxy terbutalline
- CAS:
- 28924-25-6
- MF:
- C26H31NO3
- Structure:
- Chemical Name:
- 1H-BENZIMIDAZOLE,2-CHLORO-1-(2-ETHOXYETHYL)
- CAS:
- 87233-54-3
- MF:
- C11H13ClN2O
- Chemical Name:
- LEYBOLD VACUUM PUMP OIL
- CAS:
- 64742-65-0
- Structure:
- Chemical Name:
- 2,2-Dimethyl-4-isopropyl-1,3-benzodioxole (Propofol Impurity L)
- CAS:
- 201166-22-5
- MF:
- C12H16O2
- Structure:
- Chemical Name:
- 24Dichloro-5methoxyacetanilide
- CAS:
- 65182-98-1
- MF:
- C9H9Cl2NO2
- Chemical Name:
- Bimatoprost Impurity 23
- Chemical Name:
- Oxacillin Impurity IMPA
- Chemical Name:
- Rebamipide Impurity X(Rebamipide Impurity 7)
- Structure:
- Chemical Name:
- Pyrimidine, 4,6-dichloro-5-nitroso-2-(propylthio)-
- CAS:
- 2512210-19-2
- MF:
- C7H7Cl2N3OS
- Structure:
- Chemical Name:
- 5-Pyrimidinamine, 4,6-dichloro-N-hydroxy-2-(propylthio)-
- CAS:
- 2517939-84-1
- MF:
- C7H9Cl2N3OS
- Structure:
- Chemical Name:
- (R)-4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)benzenediazonium tetrafluoroborate
- CAS:
- 1630761-21-5
- MF:
- C11H11N4O+
- Chemical Name:
- 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine 1-oxide
- Chemical Name:
- CetearylGlucoside
- CAS:
- 246159-33-1
- Chemical Name:
- Bisoprolol Impurity 40
- Structure:
- Chemical Name:
- 2,4-Pyrimidinediol, 6-chloro- (9CI)
- CAS:
- 107577-09-3
- MF:
- C4H3ClN2O2
- Chemical Name:
- Phenoxymethylpenicillin Potassium Impurity 8
- Chemical Name:
- Tegoprazan Impurity 4
- Chemical Name:
- Bumetanide Impurity 23
- Chemical Name:
- Rocuronium Bromide Impurity 34、35、36
- Structure:
- Chemical Name:
- Vinpocetine impurity C
- CAS:
- 70155-05-4
- MF:
- C23H28N2O3
- Chemical Name:
- Cloxacillin Impurity X
- Structure:
- Chemical Name:
- Benzamide, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-6,8-dithioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methyl-
- CAS:
- 2649802-40-2
- MF:
- C21H15F4N5OS2
- Structure:
- Chemical Name:
- Benzamide, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-6,8-dithioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methyl-
- CAS:
- 2649802-40-2
- MF:
- C21H15F4N5OS2
- Chemical Name:
- 1-(4-((2-(4-hydroxypiperidin-1-yl)ethyl)(methyl)carbamoyl)benzyl)piperidine-4-carboxamide
- Chemical Name:
- Azilsartan Impurity 107
- Chemical Name:
- Perospirone Impurity 25
- Chemical Name:
- Paxlovid Impurity 16
- Chemical Name:
- 3-(2-(cyclopent-1-en-1-yl)-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide
- Chemical Name:
- Fondaparinux sodium impurity 17
- Chemical Name:
- Fondaparinux sodium impurity 12
- Chemical Name:
- Piperacillin impurity L
- Chemical Name:
- Piperacillin Impurity X
- Structure:
- Chemical Name:
- ETHYLTRITYLETHER
- CAS:
- 968-39-8
- MF:
- C21H20O
- Chemical Name:
- Bosutinib Impurity 41
- Structure:
- Chemical Name:
- (S)-3-Dimethylamino-3-phenylpropanol
- CAS:
- 82769-75-3
- MF:
- C11H17NO
- Chemical Name:
- Valdecoxib N-Oxide
- Chemical Name:
- Olodaterol Impurity 23
- Chemical Name:
- Miglitol Isomer impurities C
- Structure:
- Chemical Name:
- 8-(2,3-dichlorophenyl)-5,8-diazaspiro[4.5]decan-5-ium bromide
- CAS:
- 2043655-58-7
- MF:
- C14H19Cl3N2
- Structure:
- Chemical Name:
- 8-(2,3-dichlorophenyl)-5,8-diazaspiro[4.5]decan-5-ium bromide
- CAS:
- 2043655-58-7
- MF:
- C14H19Cl3N2
- Chemical Name:
- Alpha-D-Methylglucoside
- Structure:
- Chemical Name:
- 4-Desacetyl Vincristine
- CAS:
- 3704-01-6
- MF:
- C44H54N4O9
- Chemical Name:
- Relugolix Impurity 91
- Structure:
- Chemical Name:
- D,L N-Desmethylvenlafaxine
- CAS:
- 149289-30-5
- MF:
- C16H25NO2
- Structure:
- Chemical Name:
- PIVALOYLOXYMETHYL 6-AMINOPENICILANATE
- CAS:
- 25031-08-7
- MF:
- C14H22N2O5S
- Structure:
- Chemical Name:
- NSC525120
- CAS:
- 10221-08-6
- MF:
- C8H7Cl3
- Structure:
- Chemical Name:
- 3-(2-cyanoethyl-(2-hydroxyethyl)amino)propanenitrile
- CAS:
- 6305-56-2
- MF:
- C8H13N3O
- Structure:
- Chemical Name:
- TRANS-4-[[(2-AMINOPHENYL)METHYL]AMINO]-CYCLOHEXANOL
- CAS:
- 46727-91-7
- MF:
- C13H20N2O
- Chemical Name:
- Citalopram Related Compound F