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:
- Pemetrexed
- CAS:
- 155405-79-1
- MF:
- C12H13BrO3
- Chemical Name:
- Linagliptin Impurity 53
- Structure:
- Chemical Name:
- Nintedanib Impurity 52
- CAS:
- 2410284-89-6
- MF:
- C22H30N6O2
- Chemical Name:
- Olaparib Impurity 21
- Chemical Name:
- Oseltamivir Impurity 43
- Chemical Name:
- Osimertinib Impurity 3
- Chemical Name:
- Rosuvastatin Impurity 48
- Structure:
- Chemical Name:
- Sildenafil Impurity 37
- MF:
- C22H30N6O4S
- Chemical Name:
- Sitagliptin Impurity 80
- Chemical Name:
- Teneligliptin Impurity 2
- Chemical Name:
- Ticagrelor Impurity 104
- Chemical Name:
- Ticagrelor Impurity 95
- Chemical Name:
- Tofacitinib Impurity 120
- Chemical Name:
- Vildagliptin Impurity 46
- Chemical Name:
- Carbocistein Impurity C
- Chemical Name:
- (2S,4R)-N-((2S,3S,4S)-1-(((2S,3R)-5-amino-1
- Chemical Name:
- Erythromycin Impurity 4
- Chemical Name:
- Itraconazole iMpurity 5
- Structure:
- Chemical Name:
- 2-Chloro-4'-fluorobenzophenone
- CAS:
- 1806-23-1
- MF:
- C13H8ClFO
- Structure:
- Chemical Name:
- 1-(((2R,4R)-4-((Benzyloxy)methyl)-2-(2,4-difluorophenyl)tetrahydrofuran-2-yl)methyl)-1H-1,2,4-triazole
- CAS:
- 165115-83-3
- MF:
- C21H21F2N3O2
- Structure:
- Chemical Name:
- 1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aR,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic Acid
- CAS:
- 855661-71-1
- MF:
- C21H24FN3O4
- Chemical Name:
- 4-[(4-aminohex-5-enoyl)amino]hex-5-enoic acid (mixture of the 4 stereoisomers)
- CAS:
- 748817-01-8
- Chemical Name:
- 4-[(4-aminohex-5-enoyl)amino]hex-5-enoic acid (mixture of the 4 stereoisomers)
- CAS:
- 748817-01-8
- Structure:
- Chemical Name:
- Iopamidol Impurity K
- CAS:
- 1788899-70-6
- MF:
- C17H23I2N3O8
- Structure:
- Chemical Name:
- N-(2-(diethylamino)ethyl)-2-hydroxyquinoline-4-carboxamide
- CAS:
- 87864-08-2
- MF:
- C16H21N3O2
- Structure:
- Chemical Name:
- 5-(2-Fluorophenyl)-1-(3-pyridinylsulfonyl)-1H-pyrrole-3-carboxylic acid
- CAS:
- 1883595-37-6
- MF:
- C16H11FN2O4S
- Structure:
- Chemical Name:
- Ritonavir EP Impurity B
- CAS:
- 765875-58-9
- MF:
- C28H36N4O4S
- Structure:
- Chemical Name:
- 2-[4-(2,3-DIHYDROXYPROPOXY)PHENYL]ACETAMIDE
- CAS:
- 61698-76-8
- MF:
- C11H15NO4
- Structure:
- Chemical Name:
- 3-OXO-3-(2,4,5-TRIFLUORO-3-METHOXY-PHENYL)-PROPIONIC ACID ETHYL ESTER
- CAS:
- 112811-68-4
- MF:
- C12H11F3O4
- Structure:
- Chemical Name:
- 2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-N5,N5- dimethylpyrimidine-4,5,6-triamine
- CAS:
- 1169770-52-8
- MF:
- C19H19FN8
- Chemical Name:
- Trelagliptin Impurity 15
- Chemical Name:
- Sofosbuvir Impurity 57
- Structure:
- Chemical Name:
- Celecoxib Impurity 6
- MF:
- C17H14F3N3O2S
- Chemical Name:
- Emtricitabine Impurity 6
- Chemical Name:
- Erlotinib Impurity 26
- Chemical Name:
- Fosaprepitant Impurity 5
- Structure:
- Chemical Name:
- Dapoxetine Impurity 5
- CAS:
- 1181810-25-2
- MF:
- C19H16O
- Chemical Name:
- Regorafenib Impurity 10
- Chemical Name:
- Bosutinib Impurity 7
- Chemical Name:
- Ticagrelor Impurity 12
- Structure:
- Chemical Name:
- Ticagrelor Impurity 63
- CAS:
- 2227766-79-0
- MF:
- C9H9ClFN
- Chemical Name:
- Canagliflozin Impurity 5
- Chemical Name:
- Canagliflozin Impurity 15
- Chemical Name:
- Oseltamivir Impurity 31
- Chemical Name:
- Riociguat IMpurtiy C
- Chemical Name:
- Aclidinium Bromide Impurity 1
- Chemical Name:
- Ampicillin Impurity 7
- Structure:
- Chemical Name:
- Meropenem impurity diastereomer 1
- CAS:
- 96035-27-7
- MF:
- C15H19N3O5S
- Structure:
- Chemical Name:
- methyl 4-hydroxy-6-phenoxyisoquinoline-3-carboxylate
- CAS:
- 1509958-11-5
- MF:
- C17H13NO4
- Structure:
- Chemical Name:
- Palbociclib-012
- CAS:
- 2206135-30-8
- MF:
- C41H55N11O5
- Structure:
- Chemical Name:
- (3S,4S)-3-(β-D-Glucopyranosyloxy)dihydro-3,4-bis[(4-hydroxy-3-methoxyphenyl)methyl]-2(3H)-furanone
- CAS:
- 858127-38-5
- MF:
- C26H32O12
- Chemical Name:
- Tigecycline Impurity E
- Chemical Name:
- Cefminox Impurity B
- Structure:
- Chemical Name:
- isopropyl 4-(5-(p-tolyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl) benzenesulfonate
- MF:
- C20H19F3N2O3S
- Structure:
- Chemical Name:
- 5-(hydroxymethyl)-3-[(5-nitro-2-furyl)methylideneamino]oxazolidin-2-one
- CAS:
- 41359-15-3
- MF:
- C9H9N3O6
- Structure:
- Chemical Name:
- L-GLUCONO-1,5-LACTONE
- CAS:
- 52153-09-0
- MF:
- C6H10O6
- Structure:
- Chemical Name:
- Ambrisentan Impurity E
- CAS:
- 1312092-82-2
- MF:
- C21H18N2O3
- Chemical Name:
- Axitinib Impurity 14
- Structure:
- Chemical Name:
- (1s,4s)-4-((2-amino-3-bromobenzyl)amino)cyclohexan-1-ol hydrochloride
- MF:
- C13H20BrClN2O
- Chemical Name:
- Edaravone Impurity 19
- Chemical Name:
- Linagliptin Impurity 48
- Structure:
- Chemical Name:
- (3R,5S,E)-methyl 3,5-dihydroxy-7-(4-isopropyl-2-(N-methylmethyl sulfonamido)-6-phenylpyrimidin-5-yl)hept-6-enoate
- MF:
- C23H31N3O6S
- Structure:
- Chemical Name:
- (R)-3,5-dibromo-N-((1-ethylpyrrolidin-2-yl)methyl)-2,6-dimethoxybenzamide
- MF:
- C16H22Br2N2O3
- Structure:
- Chemical Name:
- Mesna Impurity 1 (2-Ethoxy-Ethanesulfonic Acid)
- CAS:
- 90663-51-7
- MF:
- C4H10O4S
- Chemical Name:
- Vonoprazan Impurity Z-7
- Chemical Name:
- Caspofungin Impurity QA
- Chemical Name:
- Cabozantinib impurity 27
- Chemical Name:
- Cabozantinib impurity 32
- Chemical Name:
- Rivaroxaban Degradation Impurity B
- Chemical Name:
- Dapoxetine impurity 26
- Structure:
- Chemical Name:
- Pregabalin Impurity 12
- CAS:
- 1013624-61-7
- MF:
- C7H11NO3
- Chemical Name:
- Pralatrexate Impurity 6
- Chemical Name:
- Pitavastatin Impurity 37
- Chemical Name:
- Dapoxetine impurity 30
- Chemical Name:
- Lenvatinib Impurity 34
- Chemical Name:
- Sitafloxacin Impurity 18
- Chemical Name:
- Canagliflozin Impurity 47
- Chemical Name:
- Olprinone Impurity C
- Chemical Name:
- Atracurium Impurity 29
- Chemical Name:
- Posaconazole Impurity 71
- Chemical Name:
- Canagliflozin Impurity 53
- Chemical Name:
- Atracurium Impurity 32
- Chemical Name:
- Tofacitinib Impurity 104
- Chemical Name:
- Rotigotine Impurity 1
- Chemical Name:
- Afatinib impurity 49
- Chemical Name:
- Cabozantinib impurity L
- Chemical Name:
- Gadobutrol Impurity 2
- Chemical Name:
- Pemetrexed disodium EP Impurity C
- Chemical Name:
- Crisaborole Impurity 6
- Chemical Name:
- Olprinone Impurity E
- Chemical Name:
- Nicorandil Impurity D
- Structure:
- Chemical Name:
- Propyphenazone EP impurity C
- CAS:
- 2731375-50-9
- MF:
- C17H24N2O
- Structure:
- Chemical Name:
- Vardenafil Impurity 15
- CAS:
- 448184-54-1
- MF:
- C19H23N5O6S
- Structure:
- Chemical Name:
- Etoricoxib N'-Oxide
- CAS:
- 325855-71-8
- MF:
- C18H15ClN2O3S
- Structure:
- Chemical Name:
- Oseltamivir
- CAS:
- 651324-07-1
- MF:
- C26H44N2O4
- Chemical Name:
- Flucloxacillin Impurity 2
- Chemical Name:
- Cefminox Impurity 4
- Chemical Name:
- Adefovir Impurity 4
- Chemical Name:
- Febuxostat Impurity 69
- Structure:
- Chemical Name:
- Furosemide Impurity 16
- CAS:
- 133989-65-8
- MF:
- C12H12N2O6S