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:
- N-((3-(5-methyl-3-(4-(N-propionylsulfamoyl)phenyl)isoxazol-4-yl)phenyl)sulfonyl)propionamide
- MF:
- C22H23N3O7S2
- Structure:
- Chemical Name:
- FEXOFENADINE, METHYL ESTER
- CAS:
- 154825-96-4
- MF:
- C33H41NO4
- 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
- Chemical Name:
- Atracurium Impurity M
- Chemical Name:
- Cefminox Sodium impurity 1
- Chemical Name:
- Dapagliflozin Impurity 5
- Chemical Name:
- Emtricitabine Impurity E
- Structure:
- Chemical Name:
- Furosemide Impurity 4
- MF:
- C12H11ClN2O5S
- Chemical Name:
- Pitavastatin Impurity 43
- Structure:
- Chemical Name:
- ethyl 4-dimethylamino-3-hydroxy-butanoate
- CAS:
- 90227-57-9
- MF:
- C8H17NO3
- Structure:
- Chemical Name:
- 2(1H)-Pyridinone, 3,4-dihydro-
- CAS:
- 57147-25-8
- MF:
- C5H7NO
- Structure:
- Chemical Name:
- TRANS-ZEATIN GLUCOSIDE
- CAS:
- 56329-06-7
- MF:
- C16H23N5O6
- Structure:
- Chemical Name:
- 2-Diethylamino-N-(2,5-dimethyl-phenyl)-acetamide
- CAS:
- 857570-37-7
- MF:
- C14H22N2O
- Structure:
- Chemical Name:
- (R)-1-BENZYL-3-N-BOC-AMINOPIPERIDINE
- CAS:
- 216854-24-9
- MF:
- C17H26N2O2
- Structure:
- Chemical Name:
- Ibrutinib Impurity 9
- CAS:
- 2068022-09-1
- MF:
- C25H21D5N6O4
- Structure:
- Chemical Name:
- 4-CHLORO-3-HYDROXY BUTYRONITRILE
- CAS:
- 105-33-9
- MF:
- C4H6ClNO
- Structure:
- Chemical Name:
- (Z)-2-propylhept-2-enal
- CAS:
- 95667-14-4
- MF:
- C10H18O
- Structure:
- Chemical Name:
- (R)-3-AMINO-4-(2,4-DIFLUOROPHENYL)-BUTYRIC ACID-HCL
- CAS:
- 1335470-16-0
- MF:
- C10H11F2NO2
- Structure:
- Chemical Name:
- (R)-2-((3-methyl-6-(3-((1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)amino)piperidin-1-yl)-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzonitrile
- MF:
- C23H25N7O4
- Structure:
- Chemical Name:
- 4,4'-dichloro-3,3'-bis(4-ethoxybenzyl)-1,1'-biphenyl
- CAS:
- 2176485-21-3
- MF:
- C30H28Cl2O2
- Structure:
- Chemical Name:
- 3-pentylisoindolin-1-one
- CAS:
- 691863-84-0
- MF:
- C13H17NO
- Structure:
- Chemical Name:
- (1R,3R)-2-acetyl-1-(benzo[d][1,3]dioxol-5-yl)-2,3,4,9-tetrahydro- 1H-pyrido[3,4-b]indole-3-carboxylate
- CAS:
- 1598416-05-7
- MF:
- C22H20N2O5
- Structure:
- Chemical Name:
- 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N- ((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl) methyl)-N-methylmethanamine hydrochloride
- MF:
- C33H28ClF2N5O4S2
- Structure:
- Chemical Name:
- Labetalol EP impurity D
- CAS:
- 32780-65-7
- MF:
- C9H13ClN2O3
- Structure:
- Chemical Name:
- ethyl (4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl)pyrimidin-5-yl)(methyl)carbamate
- CAS:
- 625115-53-9
- MF:
- C21H21FN8O2
- Structure:
- Chemical Name:
- 2-[(4-CHLORO-2-NITROPHENYL)AMINO]-BENZOIC ACID
- CAS:
- 60091-87-4
- MF:
- C13H9ClN2O4
- Chemical Name:
- Fulvestrant impurity I
- Structure:
- Chemical Name:
- Emtricitabine
- CAS:
- 61548-81-0
- MF:
- C11H22O3S
- Structure:
- Chemical Name:
- tert-butyl 4-(3-nitropyridin-4-yl)piperazine-1-carboxylate
- CAS:
- 608142-93-4
- MF:
- C14H20N4O4
- Structure:
- Chemical Name:
- Tazobactam Impurity B
- CAS:
- 158411-82-6
- MF:
- C6H11NO3S
- Chemical Name:
- Tirofiban Impurity E
- Chemical Name:
- Tofacitinib Impurity 73
- Chemical Name:
- Tofacitinib Impurity 82
- Chemical Name:
- Apixaban Impurity 37
- Chemical Name:
- Atracurium Impurity 27
- Chemical Name:
- Aztreonam Impurity 3
- Chemical Name:
- Aztreonam Impurity 9
- Chemical Name:
- Bendamustine Impurity 24
- Structure:
- Chemical Name:
- Bosutinib Impurity 4
- CAS:
- 142072-71-7
- MF:
- C10H11NO4
- Chemical Name:
- Cefazolin EP Impurity L
- Chemical Name:
- Cefoxitin Impurity 2
- Chemical Name:
- Clotrimazole Impurity 4
- Structure:
- Chemical Name:
- Dasatinib impurity 29
- CAS:
- 1417651-54-7
- MF:
- C21H16Cl3N7OS
- Structure:
- Chemical Name:
- Erlotinib Impurity 58
- CAS:
- 2246399-22-2
- MF:
- C10H12N2O3
- Chemical Name:
- Lamivudine Impurity 4
- Chemical Name:
- Olaparib Impurity 37
- Chemical Name:
- Oseltamivir Impurity 3
- Structure:
- Chemical Name:
- Phenylephrine Impurity 2
- MF:
- C9H13NO2
- Structure:
- Chemical Name:
- Pitavastatin Impurity 23
- CAS:
- 1467166-39-7
- MF:
- C28H28FNO4
- Chemical Name:
- Pregabalin Impurity 24
- Chemical Name:
- Rocuronium Bromide Impurity 11
- Chemical Name:
- Rocuronium Bromide Impurity 24
- Chemical Name:
- Rosuvastatin EP Impurity L
- Chemical Name:
- Timolol EP Impurity J
- Chemical Name:
- Trimetazidine Impurity 7