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:
- (trans)-3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4'-fluoro-[1,1'- biphenyl]-4-yl)piperidine
- CAS:
- 1217975-87-5
- MF:
- C25H24FNO3
- Chemical Name:
- Carboprost Impurity 1
- Chemical Name:
- Beraprost Impurity 1
- Structure:
- Chemical Name:
- Benzenebutanoic acid, β-amino-2,5-difluoro-, (βR)-
- CAS:
- 936630-56-7
- MF:
- C10H11F2NO2
- Structure:
- Chemical Name:
- Cyclopropanecarboxylic acid, 1-[[(2-fluorophenyl)amino]carbonyl]-
- CAS:
- 918642-61-2
- MF:
- C11H10FNO3
- Chemical Name:
- Isavuconazole Impurity 34
- Chemical Name:
- PREDNICARBATE IMPURITY F
- Structure:
- Chemical Name:
- 2-Propanol, 1,1'-[methylenebis(4,1-phenyleneoxy)]bis[3-[(1-methylethyl)amino]-
- CAS:
- 1225195-70-9
- MF:
- C25H38N2O4
- Structure:
- Chemical Name:
- INDEX NAME NOT YET ASSIGNED
- CAS:
- 2031272-32-7
- MF:
- C47H40N4O4
- Structure:
- Chemical Name:
- (4R,5S,6S)-3-[[(3S,5S)-1-[(4-Aminophenyl)methyl]-5-[[(3-carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-Azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid Sodium Salt
- CAS:
- 866186-66-5
- MF:
- C29H33N4NaO7S
- Structure:
- Chemical Name:
- (R)-cis-5ξ-Methyl Atracurium Dibesylate
- CAS:
- 1193104-82-3
- MF:
- C60H79N2O15S+
- Chemical Name:
- 2-(((Z)-(1-(2-Aminothiazol-4-yl)-2-(((2R,3R)-2-methyl-4-oxo-1-sulfoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methylpropanoic Acid
- MF:
- C13H17N5O8S2
- Structure:
- Chemical Name:
- 7-[4-[2-[[[4-(3-Carboxy-6-fluoro-1-methyl-4-oxo-1H,4H-[1,3]thiazeto[3,2-a]quinolin-7-yl)-1-piperazinyl]carbonyl]oxy]-3-oxobutyl]-1-piperazinyl]-6-fluoro-1-methyl-4-oxo-1H,4H-[1,3]thiazeto[3,2-a]quinoline-3-carboxylic acid
- CAS:
- 156834-58-1
- MF:
- C37H36F2N6O9S2
- Structure:
- Chemical Name:
- (6R,7S)-7-ACCA
- CAS:
- 108260-07-7
- MF:
- C7H7ClN2O3S
- Structure:
- Chemical Name:
- Enrofloxacin Impurity 1
- CAS:
- 1128234-60-5
- MF:
- C19H22ClN3O3
- Chemical Name:
- Peramivir Impurity 20
- Structure:
- Chemical Name:
- Ambroxol Impurity 33
- CAS:
- 199472-91-8
- MF:
- C13H20N2O
- Structure:
- Chemical Name:
- Bilastine Impurity 12
- CAS:
- 1638785-18-8
- MF:
- C30H42N4O3
- Structure:
- Chemical Name:
- 2,5-dichloro-N,N-dimethylbenzamide
- CAS:
- 90526-01-5
- MF:
- C9H9Cl2NO
- Structure:
- Chemical Name:
- FEXOFENADINE, METHYL ESTER
- CAS:
- 154825-96-4
- MF:
- C33H41NO4
- Structure:
- Chemical Name:
- (Z)-methyl 3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylate
- CAS:
- 2093243-16-2
- MF:
- C17H13NO4
- Structure:
- Chemical Name:
- Abacavir Impurity F
- CAS:
- 1443421-68-8
- MF:
- C18H26N6O
- Chemical Name:
- Lenvatinib Impurity 10
- Chemical Name:
- Nifuratel Impurity 10
- Structure:
- Chemical Name:
- Ozagrel Impurity 16
- CAS:
- 143945-86-2
- MF:
- C13H12N2O2
- Chemical Name:
- Tofacitinib Impurity 68
- Structure:
- Chemical Name:
- 2-(4R,6S)(6-Formyl-2,2-dimethyl-[1,3]dioxan-4-yl)-acetic acid
- CAS:
- 123185-91-1
- MF:
- C9H14O5
- Structure:
- Chemical Name:
- 5-(3-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3- carbaldehyde
- MF:
- C16H11FN2O3S
- Structure:
- Chemical Name:
- Dapoxetine impurity
- CAS:
- 126113-24-4
- MF:
- C19H16O2
- Structure:
- Chemical Name:
- Loratadine Impurity 17
- CAS:
- 133330-72-0
- MF:
- C14H12ClNO
- Chemical Name:
- Prasugrel Impurity 11
- Structure:
- Chemical Name:
- someprazole Impurity 19
- CAS:
- 358675-51-1
- MF:
- C16H17N3O3S
- Chemical Name:
- Trelagliptin Impurity 18
- Structure:
- Chemical Name:
- Ropivacaine impurity
- CAS:
- 1786560-34-6
- MF:
- C12H14N2O3
- Structure:
- Chemical Name:
- N-((3-(5-methyl-3-(4-(N-propionylsulfamoyl)phenyl)isoxazol-4-yl)phenyl)sulfonyl)propionamide
- MF:
- C22H23N3O7S2
- Structure:
- Chemical Name:
- LPHE-009
- CAS:
- 64471-45-0
- MF:
- C13H16O3
- Chemical Name:
- 2-((chloro(3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)-5- (difluoromethoxy)-1Na-benzo[d]imidazole
- Structure:
- Chemical Name:
- (3S,3'S)-3,3'-((((4,4'-dichloro-[1,1'-biphenyl]-3,3'-diyl)bis (methylene))bis(4,1-phenylene))bis(oxy))bis(tetrahydrofuran)
- MF:
- C34H32Cl2O4
- Structure:
- Chemical Name:
- 4-(1,3,2-Dioxaborinan-2-yl)benzonitrile
- CAS:
- 152846-62-3
- MF:
- C10H10BNO2
- Structure:
- Chemical Name:
- Rasagiline Impurity 5 Mesylate
- CAS:
- 1312077-04-5
- MF:
- C13H15NO4S
- Structure:
- Chemical Name:
- Tadalafil Impurity 66
- CAS:
- 1598416-07-9
- MF:
- C21H18N2O5
- Chemical Name:
- Peramivir Impurity 36
- Structure:
- Chemical Name:
- 4-CHLORO-7-(2-CHLORO-ETHOXY)-6-(2-METHOXY-ETHOXY)-QUINAZOLINE
- CAS:
- 183322-20-5
- MF:
- C13H14Cl2N2O3
- Structure:
- Chemical Name:
- METHYL 2-(O-NITROBENZYLIDENE)-ACETOACETATE
- CAS:
- 39562-27-1
- MF:
- C12H11NO5
- Chemical Name:
- Sugammadex sodium Impurity 48
- Chemical Name:
- Sugammadex sodium Impurity 47
- Structure:
- Chemical Name:
- Tenofovir Impurity 95
- CAS:
- 1884329-63-8
- MF:
- C8H10BrN5
- Structure:
- Chemical Name:
- Tenofovir Impurity 117
- CAS:
- 1643116-22-6
- MF:
- C8H11N5O
- Chemical Name:
- Tafluprost Impurity E
- Chemical Name:
- Cabozantinib impurity 36
- Structure:
- Chemical Name:
- Apigenin 7-O-(2'',6''-di-O-E-p-coumaroyl)glucoside
- CAS:
- 1448779-19-8
- MF:
- C39H32O14
- Chemical Name:
- Dapoxetine impurity 69
- Structure:
- Chemical Name:
- 4-FLUORO-2-METHYLBENZAMIDE
- CAS:
- 886501-45-7
- MF:
- C8H8FNO
- Chemical Name:
- Bendamustine Related Impurity 21
- Chemical Name:
- Bendamustine Related Impurity 8
- Chemical Name:
- Bortezomib Impurity 33
- Chemical Name:
- Moxifloxacin Impurity 31
- Chemical Name:
- Pitavastatin Impurity 7
- Structure:
- Chemical Name:
- Prednisolone Impurity A
- CAS:
- 77017-17-5
- MF:
- C21H26O5
- Structure:
- Chemical Name:
- Rivaroxaban Impurity 61
- CAS:
- 1643354-27-1
- MF:
- C32H30N4O8
- Chemical Name:
- Rivaroxaban Impurity 74
- Chemical Name:
- Sitafloxacin Impurity 6
- Chemical Name:
- Ticagrelor Related Compound 75
- Structure:
- Chemical Name:
- Ticagrelor Related Compound 93
- CAS:
- 2207528-55-8
- MF:
- C23H28F2N6O4S
- Structure:
- Chemical Name:
- Vonoprazan Impurity 24
- CAS:
- 1807642-41-6
- MF:
- C16H14FN3O2S
- Chemical Name:
- Vonoprazan Impurity 35
- Chemical Name:
- Adefovir Impurity 2
- Chemical Name:
- Avibactam Impurity R
- Chemical Name:
- Blonanserin Impurity L
- Chemical Name:
- Cefazolin USP Impurity E
- Chemical Name:
- Exemestane Impurity 5
- Structure:
- Chemical Name:
- Medetomidine Impurity 28
- CAS:
- 2240179-64-8
- MF:
- C23H28N2
- Structure:
- Chemical Name:
- Peramivir Impurity 4
- CAS:
- 229615-12-7
- MF:
- C15H28N4O4
- Chemical Name:
- Peramivir Impurity 9
- Chemical Name:
- PidotimodImpurity T
- Structure:
- Chemical Name:
- Albendazole EP Impurity J
- CAS:
- 946498-41-5
- MF:
- C9H7Cl2N3O2
- Structure:
- Chemical Name:
- Ibrutinib Dimer Impurity
- CAS:
- 2031255-23-7
- MF:
- C50H48N12O4
- Structure:
- Chemical Name:
- Rifaximin EP Impurity H
- CAS:
- 1210022-90-4
- MF:
- C43H51N3O12
- Structure:
- Chemical Name:
- Voriconazole (2R,3R)-Isomer
- CAS:
- 137234-76-5
- MF:
- C16H13ClF3N5O
- Structure:
- Chemical Name:
- Diquafosol Impurity 12
- CAS:
- 694434-51-0
- MF:
- C18H26N4O23P4
- Structure:
- Chemical Name:
- Etoricoxib Impurity 39
- CAS:
- 107825-28-5
- MF:
- C13H17NOS2
- Structure:
- Chemical Name:
- Furosemide Impurity 7
- CAS:
- 4753-68-8
- MF:
- C5H8ClNO
- Structure:
- Chemical Name:
- Irinotecan Impurity 24
- CAS:
- 802277-44-7
- MF:
- C13H24N2O2
- Structure:
- Chemical Name:
- Pyridoxine Impurity 12
- CAS:
- 58947-70-9
- MF:
- C8H9NO3
- Structure:
- Chemical Name:
- Thiamine
- CAS:
- 6309-04-2
- MF:
- C13H20Br2N4OS
- Structure:
- Chemical Name:
- 1,1'-(1,4,8,11-tetraazacyclotetradecane-1,4-diyl)bis(2,2,2- trifluoroethan-1-one) dihydrochloride
- MF:
- C14H24Cl2F6N4O2
- Chemical Name:
- Empagliflozin Impurity 40
- Chemical Name:
- Empagliflozin Impurity 46
- Structure:
- Chemical Name:
- Mupirocin Impurity P/Decyl [2E,8[2S,3S(1S,2S)]]-5,9-Anhydro-2,3,4,8-tetradeoxy-8-[[3-(2-hydroxy-1-methylpropyl)oxiranyl]methyl]-3-methyl-L-talo-Non-2-enonic Acid Ester
- CAS:
- 153900-96-0
- MF:
- C27H48O7
- Structure:
- Chemical Name:
- Aprepitant
- CAS:
- 1242175-38-7
- MF:
- C20H18F7NO2
- Structure:
- Chemical Name:
- pranoprofen
- CAS:
- 143436-36-6
- MF:
- C17H19NO4
- Structure:
- Chemical Name:
- 2-[(1,3-dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]Benzonitrile
- CAS:
- 906673-30-1
- MF:
- C14H10BNO3
- Structure:
- Chemical Name:
- Fluconazole Impurity 5
- CAS:
- 154534-83-5
- MF:
- C10H9ClF2N4O
- Structure:
- Chemical Name:
- Fexofenadine N-Oxide
- CAS:
- 1422515-52-3
- MF:
- C32H39NO5
- Structure:
- Chemical Name:
- Trimetazidine Impurity 16
- CAS:
- 118709-62-9
- MF:
- C13H16O4
- Structure:
- Chemical Name:
- Ortho-Isomer of Dapagliflozin
- CAS:
- 2040305-05-1
- MF:
- C21H25ClO6
- Chemical Name:
- Acarbose Impurity H
- Structure:
- Chemical Name:
- Chidamide-13C7
- CAS:
- 1348337-81-4
- MF:
- C24H18N4O4
- Structure:
- Chemical Name:
- Imidafenacin Related Compound 9
- CAS:
- 170105-17-6
- MF:
- C21H21N3