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.
- Chemical Name:2-O-cinnamoyl-beta-D-glucose
- CAS:
- MF:
- Chemical Name:(3S)-3-((S)-1-oxo-3a,4,5,6-tetrahydro-1H-benzo[de]isoquinolin-2(3H)-yl)quinuclidine 1-oxide
- CAS:
- MF:
- Chemical Name:2-(4-hydroxy-1-methyl-7-phenoxy-5,6,7,8-tetrahydroisoquinoline-3-carboxamido)acetic acid
- CAS:
- MF:
- Structure:
- Chemical Name:Voriconazole Impurity 19
- CAS:321589-01-9
- MF:C26H28F3N5O4S
- Chemical Name:Salbutamol Impurity 38
- CAS:
- MF:
- Chemical Name:Gadobutrol Impurity 4 (Gd-DOTA)
- CAS:
- MF:
- Chemical Name:Losartan Impurity 3
- CAS:
- MF:
- Structure:
- Chemical Name:methyl 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4- (phenylcarbamoyl)-1H-pyrrol-1-yl)ethyl)-2,2-dimethyl-1,3-dioxan-4- yl)acetate
- CAS:1353049-81-6
- MF:C37H41FN2O5
- Chemical Name:Cilastatin EP Impurity G
- CAS:
- MF:
- Structure:
- Chemical Name:Rosuvastatin Impurity 122
- CAS:135999-58-5
- MF:C6H7ClO3
- Chemical Name:Anastrozole Impurity IV
- CAS:
- MF:
- Chemical Name:Anastrozole Impurity IV
- CAS:
- MF:
- Chemical Name:Modafinil Impurity B (Modafinil Sulfone)
- CAS:
- MF:
- Chemical Name:Tinidazole Impurity B
- CAS:
- MF:
- Structure:
- Chemical Name:Juncusol 7-O-glucoside
- CAS:175094-15-2
- MF:C24H28O7
- Structure:
- Chemical Name:4-Allyl-2,6-dimethoxyphenyl glucoside
- CAS:100187-70-0
- MF:C17H24O8
- Structure:
- Chemical Name:Apremilast Impurity 19
- CAS:2201974-01-6
- MF:C22H24N2O7S
- Structure:
- Chemical Name:(R)-(R)-1-methylpyrrolidin-3-yl 2-cyclopentyl-2-hydroxy-2-phenylacetate(WXC03446)
- CAS:616866-21-8
- MF:C18H25NO3
- Structure:
- Chemical Name:(R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzoic acid
- CAS:
- MF:C18H22N4O4
- Structure:
- Chemical Name:(R)-2-((6-(3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)benzoic acid
- CAS:
- MF:C18H22N4O4
- Structure:
- Chemical Name:6'-methyl-3-(4-(methylsulfonyl)phenyl)-[2,3'-bipyridin]-5-amine
- CAS:
- MF:C18H17N3O2S
- Chemical Name:Diquafosol Impurity 4
- CAS:
- MF:
- Chemical Name:Tofacitinib Impurity X
- CAS:
- MF:
- Structure:
- Chemical Name:3-pentylideneisobenzofuran-1(3H)-one
- CAS:90965-68-7
- MF:C13H14O2
- Chemical Name:Labetalol EP impurity E
- CAS:
- MF:
- Structure:
- Chemical Name:1-Propanol, 3-(2-methoxy-5-nitrophenoxy)-
- CAS:1156068-41-5
- MF:C10H13NO5
- Structure:
- Chemical Name:1616710-52-1
- CAS:1616710-52-1
- MF:C27H34N2O6
- Chemical Name:Bendamustine Related Impurity 22
- CAS:
- MF:
- Chemical Name:Bendamustine Related Impurity 9
- CAS:
- MF:
- Structure:
- Chemical Name:Edoxaban Impurity 20 (1R,2R,4S)
- CAS:1928729-31-0
- MF:C16H29N3O7
- Structure:
- Chemical Name:Edoxaban Impurity 40
- CAS:2081883-52-3
- MF:C14H27N3O3
- Chemical Name:Everolimus Impurity 2
- CAS:
- MF:
- Chemical Name:Levosimendan Impurity 2 (Mixture ofZandEIsomers)
- CAS:
- MF:
- Structure:
- Chemical Name:N-(2,3-Dichloro-phenyl)-N'-[2-(2,3-dichloro-phenylamino)-ethyl]-ethane-1,2-diamine
- CAS:
- MF:C16H17Cl4N3
- Structure:
- Chemical Name:N-(2,3-Dichloro-phenyl)-N'-[2-(2,3-dichloro-phenylamino)-ethyl]-ethane-1,2-diamine
- CAS:
- MF:C16H17Cl4N3
- Structure:
- Chemical Name:Solifenacin Related Compound 29
- CAS:861998-77-8
- MF:C23H26N2O3
- Chemical Name:Ticagrelor Impurity 31
- CAS:
- MF:
- Structure:
- Chemical Name:Ticagrelor Related Compound 46
- CAS:2205903-73-5
- MF:C28H42ClN9O8S2
- Structure:
- Chemical Name:Ticagrelor Related Compound 71
- CAS:1548397-10-9
- MF:C7H8ClN3O3S
- Chemical Name:Ticagrelor Related Compound 76
- CAS:
- MF:
- Chemical Name:Vonoprazan Impurity 25
- CAS:
- MF:
- Structure:
- Chemical Name:1-(3,4-Dimethoxyphenyl)-2-(methylsulfonyl)ethan-1-amine
- CAS:1255909-25-1
- MF:C11H17NO4S
- Structure:
- Chemical Name:Nimodipine Metabolite 3
- CAS:82219-48-5
- MF:C20H22N2O7
- Structure:
- Chemical Name:Osimertinib Impurity M
- CAS:1975982-94-5
- MF:C28H33N7O3
- Structure:
- Chemical Name:N-DEMETHYLROXITHROMYCIN
- CAS:118267-18-8
- MF:C40H74N2O15
- Chemical Name:SULPIRIDE IMPURITY A
- CAS:
- MF:
- Structure:
- Chemical Name:Androst-2-en-17-one, (5β)-
- CAS:82467-84-3
- MF:C19H28O
- Structure:
- Chemical Name:(2Z)-2,3-Dehydroxy Atorvastatin (>90% Z)
- CAS:1191901-60-6
- MF:C33H33FN2O4
- Structure:
- Chemical Name:(6α,11β)-11,21-Dihydroxy-6-methyl-pregna-1,4-diene-3,20-dione
- CAS:103744-18-9
- MF:C22H30O4
- Chemical Name:2,5-Thiazolylmethyl Diacarbonate
- CAS:144142-33-6
- MF:C28H30N4O5S2
- Structure:
- Chemical Name:4-(2-Chloroethyl)-N-methoxy-N,α,α-trimethyl-benzeneacetamide
- CAS:1638785-17-7
- MF:C14H20ClNO2
- Chemical Name:Cefuroxime Impurity A Double-Bond Shift Impurity
- CAS:
- MF:
- Structure:
- Chemical Name:4-(difluoromethoxy)-N1-((3,4-dimethoxypyridin-2-yl)methyl)benzene-1,2-diamine
- CAS:2641896-99-1
- MF:C15H17F2N3O3
- Chemical Name:Adefovir Impurity C
- CAS:
- MF:
- Chemical Name:Blonanserin Impurity M
- CAS:
- MF:
- Chemical Name:Brexpiprazole Impurity H
- CAS:
- MF:
- Chemical Name:Cefaclor EP Impurity H
- CAS:
- MF:
- Chemical Name:Flupentixol Impurity B
- CAS:
- MF:
- Structure:
- Chemical Name:Ipratropium Bromide Impurity J
- CAS:
- MF:C20H29Br2NO3
- Structure:
- Chemical Name:Taladafil impurity
- CAS:1356345-67-9
- MF:C23H23N3O4
- Structure:
- Chemical Name:Mirabegron 2-Oxo Impurity
- CAS:1684453-05-1
- MF:C21H22N4O3S
- Structure:
- Chemical Name:Riluzole 4-Bromo Impurity
- CAS:144631-82-3
- MF:C8H4BrF3N2OS
- Structure:
- Chemical Name:Furosemide Impurity 8
- CAS:41332-59-6
- MF:C7H4Cl2O5S
- Structure:
- Chemical Name:Irinotecan Impurity 29
- CAS:797762-11-9
- MF:C22H24N2O4
- Chemical Name:Empagliflozin Impurity 41
- CAS:
- MF:
- Chemical Name:Empagliflozin Impurity 47
- CAS:
- MF:
- Structure:
- Chemical Name:Irbesartan
- CAS:141745-36-0
- MF:C23H26N6O
- Structure:
- Chemical Name:Aprepitant
- CAS:170902-80-4
- MF:C20H18F7NO2
- Structure:
- Chemical Name:Pranoprofen Impurity 5
- CAS:145986-74-9
- MF:C16H15NO3
- Structure:
- Chemical Name:Fluconazole Impurity
- CAS:1609495-95-5
- MF:C15H14FN9O
- Structure:
- Chemical Name:1,4-bis(4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzyl)- 1,4,8,11-tetraazacyclotetradecane dodecahydrochloride
- CAS:
- MF:C46H96Cl12N12
- Chemical Name:Entacapone Impurity 6
- CAS:
- MF:
- Structure:
- Chemical Name:Apremilast Impurity 15
- CAS:2096492-41-8
- MF:C22H26N2O8S
- Structure:
- Chemical Name:Erythromycin EP Impurity L
- CAS:127955-44-6
- MF:C37H65NO14
- Structure:
- Chemical Name:Levetiracetam impurity 1
- CAS:1342566-28-2
- MF:C8H16N2O3
- Structure:
- Chemical Name:2-(3-(Trifluoromethyl)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl)acetohydrazide hydrochloride
- CAS:1485732-85-1
- MF:C8H11F3N6O
- Structure:
- Chemical Name:(R)-N-(1-(3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo- 1,2,3,6-tetrahydropyrimidin-4-yl)piperidin-3-yl)formamide
- CAS:2087874-91-5
- MF:C19H20FN5O3
- Chemical Name:Abiraterone Impurity 12
- CAS:
- MF:
- Chemical Name:Atracurium Impurity O
- CAS:
- MF:
- Chemical Name:Emtricitabine Impurity F
- CAS:
- MF:
- Structure:
- Chemical Name:Pitavastatin Impurity 44
- CAS:586966-55-4
- MF:C29H32FNO4
- Chemical Name:Tirofiban Impurity F
- CAS:
- MF:
- Chemical Name:Tofacitinib Impurity 74
- CAS:
- MF:
- Chemical Name:Tofacitinib Impurity 83
- CAS:
- MF:
- Structure:
- Chemical Name:Apixaban Impurity 31
- CAS:2458079-10-0
- MF:C27H30N4O6
- Chemical Name:Apixaban Impurity 38
- CAS:
- MF:
- Chemical Name:Atracurium Impurity 4
- CAS:
- MF:
- Chemical Name:Aztreonam Impurity 4
- CAS:
- MF:
- Structure:
- Chemical Name:Bendamustine Impurity 29
- CAS:847588-86-7
- MF:C19H22N6
- Chemical Name:Bendamustine Impurity 35
- CAS:
- MF:
- Chemical Name:Cefoxitin Impurity 3
- CAS:
- MF:
- Chemical Name:Doripenem Impurity 5
- CAS:
- MF:
- Chemical Name:Erlotinib Impurity 47
- CAS:
- MF:
- Structure:
- Chemical Name:Etoposide EP Impurity A
- CAS:124151-67-3
- MF:C37H38O15
- Chemical Name:Lamivudine Impurity 5
- CAS:
- MF:
- Structure:
- Chemical Name:Lercanidipine Impurity 25
- CAS:100427-22-3
- MF:C36H41N3O6
- Chemical Name:Oseltamivir Impurity 30
- CAS:
- MF:
- Structure:
- Chemical Name:Pitavastatin Impurity 25
- CAS:1356998-79-2
- MF:C19H16FN
- Chemical Name:Rocuronium Bromide Impurity 16
- CAS:
- MF: