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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- Chemical Name:
- Relugolix Impurity 1
- Structure:
- Chemical Name:
- Oseltamivir Diastereomer III HCl
- CAS:
- 2413185-95-0
- MF:
- C16H28N2O4
- Structure:
- Chemical Name:
- Rocuronium bromide impurity (3,16,17-triol)
- MF:
- C23H39NO4
- Structure:
- Chemical Name:
- 4-(4-amino-3-chlorophenoxy)-7-methoxyquinoline-6-carboxylic acid
- MF:
- C17H13ClN2O4
- Chemical Name:
- Ornidazole Impurity 26
- Chemical Name:
- Pitavastatin Impurity 73
- Chemical Name:
- Furosemide Impurity 24
- Chemical Name:
- Brivaracetam Impurity 34
- Chemical Name:
- Amoxicillin Impurity ABCDEFGHIJKLM
- Structure:
- Chemical Name:
- β-D-Glucopyranoside, [[(3R,3aS,6S,6aR)-tetrahydro-3a-hydroxy-1H,3H-furo[3,4-c]furan-3,6-diyl]bis(2-methoxy-4,1-phenylene)]bis
- CAS:
- 112747-99-6
- MF:
- C32H42O17
- Structure:
- Chemical Name:
- 1H-1,2,4-Triazole-1-propanol, α-(2,4-difluorophenyl)-α-(1H-1,2,4-triazol-1-ylmethyl)-
- CAS:
- 1222655-38-0
- MF:
- C14H14F2N6O
- Structure:
- Chemical Name:
- 3-Pyrrolidinepropanoic acid, α-[[(1,1-dimethylethoxy)carbonyl]amino]-2-oxo-, (αS,3S)-
- CAS:
- 741267-75-4
- MF:
- C12H20N2O5
- Structure:
- Chemical Name:
- Topiroxostat Impurity 44
- CAS:
- 1824131-48-7
- MF:
- C7H6N4O
- Structure:
- Chemical Name:
- Fexofenadine Impurity 12
- CAS:
- 1010812-98-2
- MF:
- C32H37NO4
- 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
- Structure:
- Chemical Name:
- TERBUTALINE IMPURITY C
- CAS:
- 139508-58-0
- MF:
- C12H17NO3
- 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
- Chemical Name:
- Butyphthalide impurity 53
- 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
- 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:
- Sugammadex sodium Org199129-1 Impurity
- Chemical Name:
- Sugammadex sodium Impurity 41
- Structure:
- Chemical Name:
- Apixaban Impurity 51
- CAS:
- 1620494-29-2
- MF:
- C33H32N4O5
- Structure:
- Chemical Name:
- 4-(5-methyl-2-phenyloxazol-4-yl)benzenesulfonamide
- CAS:
- 2242749-01-3
- MF:
- C16H14N2O3S
- Chemical Name:
- Cefazolin Impurity EP-I
- Chemical Name:
- Cabozantinib impurity 42
- Chemical Name:
- Cabozantinib impurity 55
- Chemical Name:
- Canagliflozin Impurity 68
- Chemical Name:
- Dapoxetine impurity 51
- Chemical Name:
- Doxofylline Impurity 20
- Chemical Name:
- Dapoxetine impurity 64
- Chemical Name:
- Dapoxetine impurity 58
- Chemical Name:
- Ropivacaine Impurity 50
- 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
- Chemical Name:
- CetearylGlucoside
- CAS:
- 246159-33-1
- 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:
- 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
- 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:
- 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
- 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:
- (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:
- 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
- Structure:
- Chemical Name:
- 4,4,4-trifluoro-1-(2-methylphenyl)butane-1,3-dione
- CAS:
- 163266-02-2
- MF:
- C11H9F3O2
- Structure:
- Chemical Name:
- 5-chloro-N-(4-nitrophenyl)pentanamide
- CAS:
- 1039914-85-6
- MF:
- C11H13ClN2O3
- Structure:
- Chemical Name:
- N-(2,6-dimethylphenyl)piperidine-4-carboxamide
- CAS:
- 109403-19-2
- MF:
- C14H20N2O
- Structure:
- Chemical Name:
- 5-{2-[1-(5-Hydroxy-1,5-dimethyl-hexyl)-7a-methyl-octahydro-inden-4-ylidene]-ethylidene}-4-methylene-cyclohexane-1,3-diol
- CAS:
- 73837-24-8
- MF:
- C27H44O3