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.
- Structure:
- Chemical Name:Desmethyl Ranolazine
- CAS:755711-09-2
- MF:C23H31N3O3
- Structure:
- Chemical Name:P-[[(1S)-2-(6-AMino-9H-purin-9-yl)-1-Methylethoxy]Methyl]-phosphonic Acid Monoethyl Ester
- CAS:1255525-18-8
- MF:C11H18N5O4P
- Chemical Name:RocuroniuMbroMide iMpurity B
- CAS:
- MF:
- Structure:
- Chemical Name:bis(2-(7-Methoxynaphthalen-1-yl)ethyl)aMine
- CAS:1623104-92-6
- MF:C26H28ClNO2
- Structure:
- Chemical Name:bis(2-(7-Methoxynaphthalen-1-yl)ethyl)aMine
- CAS:1623104-92-6
- MF:C26H28ClNO2
- Structure:
- Chemical Name:Methyl 2-oxo-3-((2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)biphenyl-4-yl)Methyl)-2,3-dihydro-1H-benzo[d]iMidazole-4-carboxylate
- CAS:1403474-78-1
- MF:C24H18N4O5
- Structure:
- Chemical Name:Thiazolylacetyl glycine oxiMe
- CAS:178949-03-6
- MF:C7H8N4O4S
- Structure:
- Chemical Name:3-O-Decladinosyl-6-O-Methylerythronolide A
- CAS:118058-74-5
- MF:C30H55NO10
- Structure:
- Chemical Name:16α,17-[(1RS)-Butylidenebis(oxy)]-11β-hydroxy-17-(hydroxyMethyl)-D-hoMoandrosta-1,4-diene-3,17a-dione (Mixture of DiastereoMers)
- CAS:1040085-99-1
- MF:C25H34O6
- Structure:
- Chemical Name:2-BroMo-1-cyclopropyl-2-(3-fluorophenyl)ethanone
- CAS:1359829-72-3
- MF:C11H10BrFO
- Structure:
- Chemical Name:N-((4-(5-Methyl-3-phenylisoxazol-4-yl)phenyl)sulfonyl)acetaMide
- CAS:198471-06-6
- MF:C18H16N2O4S
- Structure:
- Chemical Name:N-((S)-1-(((S)-1-Hydroxy-3-Methylbutyl)aMino)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide
- CAS:289472-81-7
- MF:C19H24N4O3
- Structure:
- Chemical Name:(Z)-N-(2-nitrovinyl)acetaMide
- CAS:1238305-24-2
- MF:C4H6N2O3
- Structure:
- Chemical Name:Azilsartan iMpurity
- CAS:1604812-35-2
- MF:C35H28N4O11
- Structure:
- Chemical Name:Azilsartan iMpurity N
- CAS:2244031-86-3
- MF:C22H17N3O4
- Chemical Name:cefoxitin iMpurity B
- CAS:
- MF:
- Chemical Name:pidotiMod iMpurity A
- CAS:
- MF:
- Structure:
- Chemical Name:DESVENLAFAXINE SUCCINATE
- CAS:448904-47-0
- MF:C20H31NO6
- Structure:
- Chemical Name:IMp. H (EP): (2R)-2-[(2,2-DiMethylpropanoyl)aMino]-2-(4-hydroxyphenyl)acetic Acid
- CAS:
- MF:C16H19N3O5S
- Structure:
- Chemical Name:Desloratadine IMpurity B
- CAS:117796-50-6
- MF:C19H19BrN2
- Chemical Name:Itraconazole IMpurity B
- CAS:
- MF:
- Structure:
- Chemical Name:Benzene, 1-(3-chloropropyl)-3-(trifluoroMethyl)-
- CAS:82258-76-2
- MF:C10H10ClF3
- Structure:
- Chemical Name:N-Methyl-N-((3S,4S)-4-Methylpiperidin-3-yl)-7H-pyrrolo[2,3-d]pyriMidin-4-aMine
- CAS:1260614-73-0
- MF:C13H19N5
- Structure:
- Chemical Name:2-(5-oxo-5H-chroMeno[2,3-b]pyridin-7-yl)propanoic acid
- CAS:52549-19-6
- MF:C15H11NO4
- Structure:
- Chemical Name:1H-BenziMidazole, 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]Methyl]sulfinyl]-1-(2,2,2-trifluoroethyl)-
- CAS:1187926-84-6
- MF:C18H15F6N3O2S
- Structure:
- Chemical Name:4,5-dihydro-a-(hydroxyMethyl)-a,3-diMethyl-5-oxo-1-phenyl-1H-Pyrazole-4-Methanesulfonic acid
- CAS:1242471-40-4
- MF:C13H16N2O5S
- Structure:
- Chemical Name:Rivaroxaban iMpurity A
- CAS:931204-39-6
- MF:C19H20ClN3O6S
- Structure:
- Chemical Name:R-7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9-fluoro-2,3-dihydro-3-Methyl-10-(4-Methyl-1-piperazinyl)-7-oxo- Methyl ester
- CAS:1268719-66-9
- MF:C19H22FN3O4
- Structure:
- Chemical Name:Ticagrelor Sulfone
- CAS:274693-39-9
- MF:C23H28F2N6O6S
- Structure:
- Chemical Name:2-(((3aR,4S,6R,6aS)-6-(7-aMino-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-2,2-diMethyltetrahydro-3aH-cyclopenta[d][1,3]dioxol-4-yl)oxy)ethanol
- CAS:1858267-99-8
- MF:C17H26N6O4S
- Structure:
- Chemical Name:(2R,3R)-2-[(1R)-1-[3,5-Bis(trifluoroMethyl)phenyl]ethoxy]-3-(4-fluorophenyl)Morpholine
- CAS:380499-06-9
- MF:C20H18F7NO2
- Structure:
- Chemical Name:Adefovir iMpurity
- CAS:1875153-79-9
- MF:C15H24N5O6P
- Chemical Name:Anastrozole iMpurity
- CAS:
- MF:
- Chemical Name:Anastrozole iMpurity
- CAS:
- MF:
- Chemical Name:LevosiMendan iMpurity
- CAS:139052-02-1
- MF:
- Structure:
- Chemical Name:(Z)-3-((2'-(N'-hydroxycarbaMiMidoyl)biphenyl-4-yl)Methyl)-2-oxo-2,3-dihydro-1H-benzo[d]iMidazole-4-carboxylic acid
- CAS:1174733-90-4
- MF:C10H14N4O6
- Structure:
- Chemical Name:rac Cinacalcet HCl
- CAS:1025064-33-8
- MF:C22H22F3N
- Chemical Name:Acyclovir IMpurity I
- CAS:
- MF:
- Chemical Name:AtracuriuM Besylate IMpurity D Iodide (Mixture of DiastereoMers)
- CAS:
- MF:
- Chemical Name:AzithroMycin IMpurity D
- CAS:
- MF:
- Chemical Name:AztreonaM IMpurity E
- CAS:
- MF:
- Chemical Name:Dasatinib IMpurity 1
- CAS:
- MF:
- Chemical Name:Deferasirox IMpurity 1
- CAS:
- MF:
- Structure:
- Chemical Name:Doxycycline Hyclate IMpurity F
- CAS:122861-53-4
- MF:C23H25NO8
- Structure:
- Chemical Name:IpratropiuM BroMide IMpurity E
- CAS:183626-76-8
- MF:C19H27NO3
- Structure:
- Chemical Name:Minoxidil IMpurity D
- CAS:75105-16-7
- MF:C11H12N4O4S
- Structure:
- Chemical Name:Epalrestat iMpurity
- CAS:109801-00-5
- MF:C13H18O
- Structure:
- Chemical Name:5-Oxo Pitavastatin
- CAS:222306-15-2
- MF:C25H22FNO4
- Structure:
- Chemical Name:(3R)-2,3-Dihydro-3-(2-propyn-1-ylaMino)-1H-inden-1-one
- CAS:1312077-05-6
- MF:C12H11NO
- Structure:
- Chemical Name:1-[[2'-(AMinoiMinoMethyl)[1,1'-biphenyl]-4-yl]Methyl]-2-ethoxy-1H-benziMidazole-7-carboxylic Acid
- CAS:1442400-65-8
- MF:C24H22N4O3
- Structure:
- Chemical Name:2-Hydroxy Cephalexin
- CAS:215172-75-1
- MF:C16H17N3O5S
- Structure:
- Chemical Name:3-(9H-Carbazol-4-yloxy)-1,2-propanediol
- CAS:123119-89-1
- MF:C15H15NO3
- Structure:
- Chemical Name:4-(2-Methylpropoxy)-1,3-benzenedicarbothioaMide
- CAS:1330632-46-6
- MF:C12H16N2OS2
- Structure:
- Chemical Name:(3S,5S)-Fluvastatin Sodium Salt
- CAS:194935-01-8
- MF:C24H27FNNaO4
- Structure:
- Chemical Name:Betaxolol EP Impurity A
- CAS:67193-95-7
- MF:C14H23NO2
- Structure:
- Chemical Name:3,5-Bis(benzyloxy)benzoic acid benzyl ester
- CAS:50513-72-9
- MF:C28H24O4
- Structure:
- Chemical Name:[(2,3-Dihydro-1,5-dimethyl-3-oxo-2-phenyl-1H-pyrazol-4-yl)amino]methanesulfonic acid
- CAS:117-38-4
- MF:C12H15N3O4S
- Structure:
- Chemical Name:p-Methylcinnamic acid ethyl ester
- CAS:24393-49-5
- MF:C12H14O2
- Structure:
- Chemical Name:3-[(2-Hydroxyethyl)amino]propiononitrile
- CAS:33759-44-3
- MF:C5H10N2O
- Structure:
- Chemical Name:2-Amino-5-bromobenzaldehyde
- CAS:29124-57-0
- MF:C7H6BrNO
- Structure:
- Chemical Name:(R)-(+)-3-(N-METHYLAMINO)-1-(2-THIENYL)-1-PROPANOL
- CAS:116539-57-2
- MF:C8H13NOS
- Structure:
- Chemical Name:3-OXO-3,4-DIHYDROPYRAZINE-2-CARBONITRILE
- CAS:81411-78-1
- MF:C5H3N3O
- Structure:
- Chemical Name:RP 48497 (Eszopiclone Impurity C)
- CAS:148891-53-6
- MF:C11H7ClN4O
- Structure:
- Chemical Name:3-(1-methyl-1H-indole-3-carbonyl)hexanedioic acid
- CAS:1352491-75-8
- MF:C16H17NO5
- Structure:
- Chemical Name:Decladinose Roxithromycin (Roxithromycin Impurity B)
- CAS:214902-82-6
- MF:C33H62N2O12
- Structure:
- Chemical Name:Unii-o0p4I5851i
- CAS:139563-29-4
- MF:C28H37ClN4O2S
- Structure:
- Chemical Name:Amoxicillin Diketopiperazine (Mixture of Diastereomers)
- CAS:94659-47-9
- MF:C16H19N3O5S
- Structure:
- Chemical Name:Amoxicillin Diketopiperazine (Mixture of Diastereomers)
- CAS:94659-47-9
- MF:C16H19N3O5S
- Structure:
- Chemical Name:Atorvastatin Oxirane Impurity
- CAS:1246818-88-1
- MF:C26H24FNO3
- Structure:
- Chemical Name:Dehydro Lovastatin
- CAS:109273-98-5
- MF:C24H34O4
- Structure:
- Chemical Name:(3S)-3-[3-[(1E)-2-(7-Chloro-2-quinolinyl)ethenyl]phenyl]-4,5-dihydro-2-benzoxepin-1(3H)-one
- CAS:1100617-38-6
- MF:C27H20ClNO2
- Structure:
- Chemical Name:O-Desethyl N-Trityl Candesartan Cilexetil
- CAS:934495-65-5
- MF:C50H44N6O6
- Structure:
- Chemical Name:rac Des(isopropoxyethyl)-2-isopropoxyethoxymethyl Bisoprolol
- CAS:1215342-36-1
- MF:C19H33NO5
- Structure:
- Chemical Name:N-(Ethylamino) Fluvoxamine
- CAS:1217262-11-7
- MF:C17H26F3N3O2
- Structure:
- Chemical Name:Iso Ribavirin (Ribavirin Impurity G)
- CAS:39030-43-8
- MF:C8H12N4O5
- Structure:
- Chemical Name:(R)-(+)-Tolvaptan
- CAS:331947-66-1
- MF:C26H25ClN2O3
- Structure:
- Chemical Name:(Z)-Cefdinir
- CAS:178601-88-2
- MF:C14H13N5O5S2
- Chemical Name:Flucloxacillin impurity E
- CAS:
- MF:
- Structure:
- Chemical Name:4-(4-Piperidyl)-1-butanol
- CAS:57614-92-3
- MF:C9H19NO
- Structure:
- Chemical Name:rac N,N-DidesMethyl-N-(4-hydroxyphenethyl)-O-desMethyl Venlafaxine
- CAS:1346601-21-5
- MF:C22H29NO3
- Structure:
- Chemical Name:rac-11-Deoxy-8(12)-dehydro Misoprostol
- CAS:1331639-92-9
- MF:C22H36O4
- Structure:
- Chemical Name:5-Nitro-1H-iMidazole-1-ethanol
- CAS:5006-68-8
- MF:C5H7N3O3
- Structure:
- Chemical Name:Hydroxy Adapalene
- CAS:1346599-76-5
- MF:C28H28O4
- Chemical Name:Iohexol related Compound I
- CAS:
- MF:
- Structure:
- Chemical Name:1-(2,3-dichlorophenyl)-4-(4-hydroxybutyl)piperazine
- CAS:870765-38-1
- MF:C14H20Cl2N2O
- Structure:
- Chemical Name:2,2'-Methylene Bis[Ranitidine]
- CAS:207592-21-0
- MF:C27H44N8O6S2
- Structure:
- Chemical Name:ChloroMethyl Propyl Carbonate
- CAS:35273-90-6
- MF:C5H9ClO3
- Structure:
- Chemical Name:2-AMino-5-(trifluoroMethoxy)phenyl Thiocyanate
- CAS:1391054-04-8
- MF:C8H5F3N2OS
- Structure:
- Chemical Name:Bisacodyl Related Compound B (20 mg) (2,4'-(Pyridin-2-ylmethylene)diphenol)
- CAS:16985-05-0
- MF:C18H15NO2
- Structure:
- Chemical Name:Doxepin Related Compound C (25 mg) ((E-3-(dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-amine hydrochloride)
- CAS:4504-96-5
- MF:C18H20ClNO
- Structure:
- Chemical Name:Imiquimod Related Compound B (25 mg) (1-Isobutyl-1H-imidazo[4,5-c]quinoline 5-oxide)
- CAS:99010-63-6
- MF:C14H15N3O
- Structure:
- Chemical Name:Ioversol Related Compound B (50 mg) (N,N'-bis(2,3-dihydroxypropyl)-5-[(N-(2-hydroxyethyl)-carbamoyl)methoxy]-2,4,6-triiodoisophthalamide)
- CAS:104517-96-6
- MF:C18H24I3N3O9
- Chemical Name:Ribavirin IMp. D (EP)
- CAS:
- MF:
- Structure:
- Chemical Name:SalMeterol IMpurity C
- CAS:
- MF:C25H37NO4
- Chemical Name:SulbactaM IMpurity F
- CAS:
- MF:
- Structure:
- Chemical Name:5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde
- CAS:881677-11-8
- MF:C16H11FN2O3S
- Structure:
- Chemical Name:N-(4-(2-Methyl-1,4,5,6-tetrahydrobenzo[b]iMidazo[4,5-d]azepine-1-carbonyl)phenyl)-[1,1'-biphenyl]-2-carboxaMide
- CAS:
- MF:C32H26N4O2
- Structure:
- Chemical Name:1-(4-Methoxyphenyl)-6-(4-(2-Methyl-6-oxopiperidin-1-yl)phenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide
- CAS:2098457-92-0
- MF:C26H27N5O4
- Structure:
- Chemical Name:1-(4-Methoxyphenyl)-6-(4-(2-Methyl-6-oxopiperidin-1-yl)phenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxaMide
- CAS:2098457-92-0
- MF:C26H27N5O4