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:
- 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:
- 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
- Structure:
- Chemical Name:
- 5-(hydroxymethyl)-3-[(5-nitro-2-furyl)methylideneamino]oxazolidin-2-one
- CAS:
- 41359-15-3
- MF:
- C9H9N3O6
- Structure:
- Chemical Name:
- Ambrisentan Impurity E
- CAS:
- 1312092-82-2
- MF:
- C21H18N2O3
- Structure:
- Chemical Name:
- 6-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)- 7,9-dihydro-8H-purin-8-one
- CAS:
- 1361569-10-9
- MF:
- C18H13FN8O
- Chemical Name:
- Apremilast impurity 32
- Chemical Name:
- Baricitinib Impurity 5
- Chemical Name:
- Bendamustine Impurity 28
- Chemical Name:
- Bortezomib Impurity 20
- Structure:
- Chemical Name:
- Canagliflozin Impurity 27
- CAS:
- 2265214-89-7
- MF:
- C18H14BrFS
- Chemical Name:
- Edoxaban Impurity 23 (1S,2S,4R)
- Structure:
- Chemical Name:
- Edoxaban Impurity 38
- CAS:
- 2081883-53-4
- MF:
- C14H27N3O3
- Structure:
- Chemical Name:
- Ezetimibe Impurity 33
- CAS:
- 1829558-53-3
- MF:
- C13H10FNO
- Chemical Name:
- Imatinib Impurity 14
- Structure:
- Chemical Name:
- Levofloxacin Impurity 20
- MF:
- C18H20FN3O4
- Chemical Name:
- Pantoprazole Impurity 12
- Chemical Name:
- Solifenacin Related Compound 7
- Chemical Name:
- Vonoprazan Impurity 12
- Chemical Name:
- Apixaban Impurity 22
- Chemical Name:
- Avibactam Impurity A
- Chemical Name:
- Avibactam Impurity F
- Chemical Name:
- Brexpiprazole Impurity K
- Chemical Name:
- Cefaclor Impurity 3
- Structure:
- Chemical Name:
- Milrinone Impurity 7
- CAS:
- 2250242-59-0
- MF:
- C14H13N3O
- Chemical Name:
- Silodosin Impurity 1
- Chemical Name:
- Sulpiride Impurity 1
- Chemical Name:
- Tenofovir Impurity 54
- Structure:
- Chemical Name:
- Trelagliptin Impurity Y
- CAS:
- 1938080-42-2
- MF:
- C13H10FN3O3
- Chemical Name:
- Cefathiamidine Impurity 10
- Structure:
- Chemical Name:
- Nebivolol Impurity 3
- CAS:
- 1029684-20-5
- MF:
- C18H20FNO2
- Structure:
- Chemical Name:
- Pemetrexed
- CAS:
- 155405-79-1
- MF:
- C12H13BrO3
- 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:
- Axitinib Impurity 14
- Chemical Name:
- Nicorandil Impurity 7
- Structure:
- Chemical Name:
- Ritonavir EP Impurity T
- CAS:
- 869368-48-9
- MF:
- C46H66N8O5S2
- Structure:
- Chemical Name:
- 4-Methoxy-a-methyl-L-phenylalanine
- CAS:
- 65555-88-6
- MF:
- C11H15NO3
- Structure:
- Chemical Name:
- Cyanocobalamin
- CAS:
- 38218-55-2
- MF:
- C63H87CoN13O15P
- Chemical Name:
- Empagliflozin Impurity 44
- Structure:
- Chemical Name:
- 1,4,8,11- tetra(trifluoroacetyl)-1,4,8,11-tetraazacyclotetradecane
- CAS:
- 201610-16-4
- MF:
- C18H20F12N4O4
- Structure:
- Chemical Name:
- 5-bromo-4-(4-chlorothiophen-2-yl)thiazol-2-amine
- CAS:
- 2161380-87-4
- MF:
- C7H4BrClN2S2
- Chemical Name:
- Zopiclone Impurity 11
- Structure:
- Chemical Name:
- (3R,5S)-5-((R)-8-fluoro-4-isopropyl-2-(N-methylmethylsulfonam ido)-5,6-dihydrobenzo[h]quinazolin-6-yl)-3,5-dihydroxypentanoate calcium(II)
- CAS:
- 854898-49-0
- MF:
- C44H54CaF2N6O12S2
- Structure:
- Chemical Name:
- Doxorubicin EP Impurity C HBr
- CAS:
- 60873-68-9
- MF:
- C27H29Br2NO10
- Chemical Name:
- Ceftazidime Impurity K
- Structure:
- Chemical Name:
- Furosemide Impurity 3
- MF:
- C12H11ClN2O5S
- 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