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:Isavuconazole Impurity 8
- CAS:
- MF:
- Chemical Name:Lenvatinib Impurity 3
- CAS:
- MF:
- Chemical Name:Linagliptin Impurity 44
- CAS:
- MF:
- Chemical Name:MiraBegron impurity E
- CAS:
- MF:
- Chemical Name:Moxifloxacin Impurity 16
- CAS:
- MF:
- Structure:
- Chemical Name:Nifedipine Impurity H
- CAS:74936-71-3
- MF:C16H16N2O6
- Chemical Name:Plerixafor Impurity 3
- CAS:
- MF:
- Chemical Name:Posaconazole Impurity 27
- CAS:
- MF:
- Structure:
- Chemical Name:Posaconazole Impurity 44
- CAS:357189-97-0
- MF:C21H20F2N4O3
- Chemical Name:Pramipexole Impurity 10
- CAS:
- MF:
- Chemical Name:rac N-Propyl-2-cyanimidopyrrolidine-5-acetic Acid
- CAS:
- MF:
- Chemical Name:sofosBuvir Impurity 33
- CAS:
- MF:
- Chemical Name:sofosBuvir impurity 49
- CAS:
- MF:
- Chemical Name:SofosBuvir Impurity 55
- CAS:
- MF:
- Structure:
- Chemical Name:Tenofovir Impurity W
- CAS:1244022-55-6
- MF:C15H24N5O8P
- Chemical Name:TerButaline Ep Impurity B
- CAS:
- MF:
- Structure:
- Chemical Name:Timolol EP Impurity H
- CAS:158636-97-6
- MF:C13H24N4O3S
- Chemical Name:Tirofiban Impurity 11
- CAS:
- MF:
- Structure:
- Chemical Name:8-(2,3-Dichlorophenyl)-8-aza-5-azoniaspiro[4.5]decane BroMide
- CAS:795313-24-5
- MF:C14H19BrCl2N2
- Structure:
- Chemical Name:8-(2,3-Dichlorophenyl)-8-aza-5-azoniaspiro[4.5]decane BroMide
- CAS:795313-24-5
- MF:C14H19BrCl2N2
- Structure:
- Chemical Name:9-MethoxyMethyl Guanine
- CAS:1202645-50-8
- MF:C7H9N5O2
- Structure:
- Chemical Name:ClindaMycin 3-PalMitate
- CAS:68225-59-2
- MF:C34H63ClN2O6S
- Structure:
- Chemical Name:EltroMbopag Methyl Ester
- CAS:1246929-01-0
- MF:C26H24N4O4
- Structure:
- Chemical Name:ErythroMycin A 6,9-IMino Ether
- CAS:99290-97-8
- MF:C37H66N2O12
- Structure:
- Chemical Name:Tofacitinib Impurity 45
- CAS:2407039-29-4
- MF:C16H20N6O2
- Chemical Name:Tofacitinib impurity S
- CAS:
- MF:
- Chemical Name:Trelagliptin Impurity 25
- CAS:
- MF:
- Structure:
- Chemical Name:Valaciclovir EP Impurity H
- CAS:84499-64-9
- MF:C11H16N6O4
- Structure:
- Chemical Name:Lidocaine EP Impurity F
- CAS:142713-08-4
- MF:C14H22N2O
- Chemical Name:Ampicillin Impurity P
- CAS:
- MF:
- Chemical Name:Cefdinir Impurity B (CP)
- CAS:
- MF:
- Chemical Name:Cloxacillin Impurity A
- CAS:
- MF:
- Structure:
- Chemical Name:Erythromycin Impurity E(EP)
- CAS:857839-61-3
- MF:C37H65NO12
- Structure:
- Chemical Name:Meropenem Trihydrate Impurity B
- CAS:166901-45-7
- MF:C34H50N6O10S2
- Structure:
- Chemical Name:Oxacillin Sodium Impurity D(EP)
- CAS:1642559-63-4
- MF:C18H21N3O4S
- Chemical Name:Oxacillin Sodium Impurity J(EP)
- CAS:
- MF:
- Chemical Name:Spectinomycin Impurity A
- CAS:
- MF:
- Structure:
- Chemical Name:2,7-Dimethyl-1,4-dihydroxynaphthalene 1-O-glucoside
- CAS:839711-70-5
- MF:C18H22O7
- Structure:
- Chemical Name:Eriodictyol-6-glucoside
- CAS:118040-45-2
- MF:C21H22O11
- Structure:
- Chemical Name:Rubrofusarin triglucoside
- CAS:245724-07-6
- MF:C33H42O20
- Structure:
- Chemical Name:Gabapentin EP Impurity G
- CAS:1500558-49-5
- MF:C10H19NO2
- Structure:
- Chemical Name:2-butyrylbenzoic acid
- CAS:19666-03-6
- MF:C11H12O3
- Chemical Name:Cefminox sodium impurities D
- CAS:
- MF:
- Structure:
- Chemical Name:(R)-5-chloro-N-(4-(3-oxomorpholino)phenyl)-N- ((2-oxooxazolidin-5-yl)methyl)thiophene-2-carboxamide
- CAS:1879903-65-7
- MF:C19H18ClN3O5S
- Structure:
- Chemical Name:Cefmetazole impurity
- CAS:56796-19-1
- MF:C28H27N7O5S3
- Structure:
- Chemical Name:3-ethylisobenzofuran-1(3H)-one
- CAS:17475-41-1
- MF:C10H10O2
- Structure:
- Chemical Name:Ivabradine Impurity 21 HCl
- CAS:304465-03-0
- MF:C26H34N2O5
- Chemical Name:Moxifloxacin EP Impurity C HCl
- CAS:
- MF:
- Structure:
- Chemical Name:Moxifloxacin Impurity 23
- CAS:855661-74-4
- MF:C21H24FN3O4
- Structure:
- Chemical Name:Solifenacin Related Compound 18
- CAS:1225338-27-1
- MF:C23H26N2O2
- Structure:
- Chemical Name:N-(2-hydroxy-3-(4-((2-isopropoxyethoxy)methyl)phenoxy)propyl) -N-isopropylformamide
- CAS:1447715-45-8
- MF:C19H31NO5
- Structure:
- Chemical Name:Tofacitinib Related Compound
- CAS:1206824-85-2
- MF:C10H18ClN3O
- Structure:
- Chemical Name:Fluvastatin EP impurity A -G
- CAS:93957-58-5
- MF:C24H26FNO4
- Structure:
- Chemical Name:PWKRNMKZGWGSDV-UHFFFAOYSA-N
- CAS:1422960-88-0
- MF:C33H34ClN4+
- Structure:
- Chemical Name:Edoxaban Impurity 12 (1R,2R,4S)
- CAS:500572-10-1
- MF:C24H30ClN7O4S
- Structure:
- Chemical Name:paroxetine Mesylate
- CAS:217797-14-3
- MF:C20H24FNO6S
- Structure:
- Chemical Name:4-(4-fluoro-3-(piperazine-1-carbonyl)benzyl)phthalazin-1(2H)-one
- CAS:763111-47-3
- MF:C20H19FN4O2
- Structure:
- Chemical Name:α,α'-Bis[(2-Methoxyphenoxy)Methyl]-1,4-piperazinediethanol
- CAS:333749-57-8
- MF:C24H34N2O6
- Structure:
- Chemical Name:Ticagrelor IMpurity E
- CAS:1402150-34-8
- MF:C26H30F2N6O5S
- Structure:
- Chemical Name:Benzenebutanoicacid,b-[[(1,1-diMethylethoxy)carbonyl]aMino]-2,4,5-trifluoro-,Methylester,(bR)-
- CAS:881995-73-9
- MF:C16H20F3NO4
- Structure:
- Chemical Name:Bosutinib Impurity 1
- CAS:1460227-29-5
- MF:C18H13Cl2N3O3
- Structure:
- Chemical Name:tert-butyl 4-cyclohexylpiperazine-1-carboxylate
- CAS:1224935-95-8
- MF:C15H28N2O2
- Chemical Name:Afatinib IMpurity D
- CAS:
- MF:
- Chemical Name:Afatinib IMpurity D
- CAS:
- MF:
- Structure:
- Chemical Name:Avanafil iMpurity 1
- CAS:372117-54-9
- MF:C18H22ClN5O3
- Structure:
- Chemical Name:Bisoprolol EP IMpurity B HeMifuMarate (Bisoprolol n-Propyl Derivative HeMifuMarate)
- CAS:1447715-44-7
- MF:C18H31NO4
- Structure:
- Chemical Name:Dabigatran iMpurity F
- CAS:1642853-67-5
- MF:C19H20N4O4
- Structure:
- Chemical Name:Decitabine iMpurity 4
- CAS:863396-35-4
- MF:C6H12O4
- Structure:
- Chemical Name:Gliclazide iMpurity D
- CAS:1136426-19-1
- MF:C15H20N2O3S
- Structure:
- Chemical Name:Losartan IMpurity C (Isolosartan)
- CAS:114799-13-2
- MF:C22H23ClN6O
- Structure:
- Chemical Name:Posaconazole DiastereoisoMer interMediate 2
- CAS:166583-12-6
- MF:C21H21F2N3O4S
- Structure:
- Chemical Name:Quetiapine IMpurity P (11-(4-Ethylpiperazin-1-yl)dibenzo[b,f][1,4]thiazepine fuMarate))
- CAS:1011758-03-4
- MF:C19H21N3S
- Structure:
- Chemical Name:TaMsulosin IMpurity B
- CAS:
- MF:C20H28N2O5S
- Chemical Name:Ticagrelor iMpurity N
- CAS:
- MF:
- Structure:
- Chemical Name:Tirofiban IMpurity (4,4'-Dipyridyl-1,5-Pentane)
- CAS:25382-33-6
- MF:C15H18N2
- Structure:
- Chemical Name:3-Quinolinecarbonitrile,4-chloro-6-Methoxy-7-[3-(4-Methyl-1-piperazinyl)propoxy]-
- CAS:492444-39-0
- MF:C19H23ClN4O2
- Structure:
- Chemical Name:Vardenafil Oxopiperazine (IMpurity)
- CAS:448184-58-5
- MF:C21H26N6O5S
- Structure:
- Chemical Name:IverMectin B1 Aglycon
- CAS:73162-95-5
- MF:C34H50O8
- Structure:
- Chemical Name:9α-BroMobudesonide
- CAS:313474-59-8
- MF:C25H33BrO6
- Structure:
- Chemical Name:N-(5-Chloro-2-pyridinyl)-2-pyrazinecarboxaMide (Zopiclone IMpurity)
- CAS:349125-10-6
- MF:C10H7ClN4O
- Structure:
- Chemical Name:2-Methyl SiMvastatin (Mixture Of DiasteroisoMers)
- CAS:774611-54-0
- MF:C26H40O5
- Structure:
- Chemical Name:(4-Chloro-3,5-diMethylpyridin-2-yl)Methanol Hydrochloride
- CAS:143016-70-0
- MF:C8H11Cl2NO
- Structure:
- Chemical Name:AMoxicillin DiMer (penicilloic acid forM)
- CAS:210289-72-8
- MF:C32H40N6O11S2
- Structure:
- Chemical Name:AMoxicillin DiMer (penicilloic acid forM)
- CAS:210289-72-8
- MF:C32H40N6O11S2
- Structure:
- Chemical Name:Desacetyl-7-ACA Lactone
- CAS:184696-69-3
- MF:C8H8N2O3S
- Structure:
- Chemical Name:5,6-DiMethoxy-2-[(4-piperidyl)Methyl]indane Hydrochloride (Donepezil IMpurity)
- CAS:1034439-43-4
- MF:C17H26ClNO2
- Structure:
- Chemical Name:CarfilzoMib IMpurity
- CAS:1541171-65-6
- MF:C41H61N5O10S
- Structure:
- Chemical Name:S,S-Efinaconazole
- CAS:164650-45-7
- MF:C18H22F2N4O
- Chemical Name:BendaMustine IMpurity
- CAS:
- MF:
- Structure:
- Chemical Name:Acetic acid, 2-chloro-2-[2-(2-Methoxyphenyl)hydrazinylidene]-, ethyl ester
- CAS:85014-68-2
- MF:C11H13ClN2O3
- Structure:
- Chemical Name:D-Alanine, N-[[P(S),2'R]-2'-cyano-2'-deoxy-2'-Methyl-P-phenyl-5'-cytidylyl]-, 1-Methylethyl ester
- CAS:1496552-28-3
- MF:C22H29FN3O9P
- Structure:
- Chemical Name:D-Glucitol, 1,5-anhydro-1-C-[4-Methyl-3-[(5-phenyl-2-thienyl)Methyl]phenyl]-, (1S)-
- CAS:842133-16-8
- MF:C24H26O5S
- Structure:
- Chemical Name:Phthalic acid, 3,3'-azoxydi- (8CI)
- CAS:22895-28-9
- MF:C16H10N2O9
- Structure:
- Chemical Name:(alphaE)-alpha-[(3,4-Dihydroxy-5-nitrophenyl)methylene]-beta-oxo-1-piperidinepropanenitrile
- CAS:1150310-15-8
- MF:C15H15N3O5
- Structure:
- Chemical Name:(2E)-2-Cyano-3-(3-ethoxy-4-hydroxy-5-nitrophenyl)-N,N-diethyl-2-propenamide
- CAS:857629-79-9
- MF:C16H19N3O5
- Structure:
- Chemical Name:(R,E)-ethyl 5-([1,1'-biphenyl]-4-yl)-4-((tert-butoxycarbonyl)aMino)-2-Methylpent-2-enoate
- CAS:149709-59-1
- MF:C25H31NO4
- Structure:
- Chemical Name:1-(3-AMinopropyl)-4-(2-Methoxyphenyl)piperazine 97%
- CAS:20529-23-1
- MF:C14H23N3O
- Structure:
- Chemical Name:(R)-3-((S)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one
- CAS:404874-94-8
- MF:C20H20FNO4
- Structure:
- Chemical Name:(S)-3-((S)-5-hydroxy-5-phenylpentanoyl)-4-phenyloxazolidin-2-one
- CAS:
- MF:C20H21NO4
- Structure:
- Chemical Name:Apixaban Impurity 20
- CAS:1421823-20-2
- MF:C27H29ClN4O5