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:3-Hydroxy loratadine
- CAS:183483-15-0
- MF:C22H23ClN2O3
- Structure:
- Chemical Name:Dehydro Lacidipine
- CAS:130996-24-6
- MF:C26H31NO6
- Structure:
- Chemical Name:Granisetron Impurity F
- CAS:1364914-39-5
- MF:C18H24N4O
- Structure:
- Chemical Name:Solifenacin N-Oxide
- CAS:180272-28-0
- MF:C23H26N2O3
- Chemical Name:Rosuvastatin Impurity 172
- CAS:
- MF:
- Structure:
- Chemical Name:pefloxacin N-oxide
- CAS:85145-21-7
- MF:C17H20FN3O4
- Structure:
- Chemical Name:2,3-dimethyl-1,4-naphthoquinone
- CAS:2197-57-1
- MF:C12H10O2
- Structure:
- Chemical Name:(1-ETHYL-3-PIPERIDINYL)METHYLAMINE
- CAS:102459-02-9
- MF:C8H18N2
- Structure:
- Chemical Name:8-HYDROXY MIRTAZAPINE
- CAS:102335-57-9
- MF:C17H19N3O
- Structure:
- Chemical Name:1-[2-Amino-1-(4-benzyloxyphenyl)-ethyl]-cyclohexanol
- CAS:93413-61-7
- MF:C23H31NO2
- Structure:
- Chemical Name:7-CHLORO-1,3DIHYDRO-5-FLUOROPHENYL-2-NITRO-METHYLENE-2H-1,4-BENZODIAZEPINE-4-OXIDE
- CAS:60656-76-0
- MF:C16H11ClFN3O3
- Chemical Name:Oseltamivir Impurity 107
- CAS:
- MF:
- Chemical Name:Oseltamivir Impurity 66
- CAS:
- MF:
- Structure:
- Chemical Name:11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepine-2-carbaldehyde
- CAS:2519517-78-1
- MF:C20H22ClNO2
- Chemical Name:32,43,50-Tricarboxy-cyanoco balamin
- CAS:
- MF:
- Structure:
- Chemical Name:(S)-Azelastine
- CAS:143228-85-7
- MF:C22H24ClN3O
- Chemical Name: Relugolix Impurity 92
- CAS:
- MF:
- Structure:
- Chemical Name:N-Desethyl Vardenafil
- CAS:448184-46-1
- MF:C21H28N6O4S
- Structure:
- Chemical Name:PHORBOL
- CAS:17673-25-5
- MF:C20H28O6
- Structure:
- Chemical Name:TRANS-4-AMINOCROTONIC ACID
- CAS:38090-53-8
- MF:C4H7NO2
- Chemical Name:Ganciclovir EP Impurity
- CAS:
- MF:
- Chemical Name:Crisaborole Impurity 15
- CAS:
- MF:
- Chemical Name:Latamoxef impurity A
- CAS:
- MF:
- Structure:
- Chemical Name:5,8-Dihydroxy-1,4-bis-[2-(2-hydroxy-ethylamino)-ethylamino]-2,3-dihydro-anthraquinone
- CAS:70476-74-3
- MF:C22H30N4O6
- Structure:
- Chemical Name:4-Acetyl-2-fluorobiphenyl
- CAS:42771-79-9
- MF:C14H11FO
- Structure:
- Chemical Name:m-xylene-4,alpha,alpha'-triol
- CAS:2937-60-2
- MF:C8H10O3
- Structure:
- Chemical Name:Benzonitrile, 2-[(3,4-dihydro-6-methoxy-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl)methyl]-
- CAS:2514763-78-9
- MF:C14H13N3O3
- Structure:
- Chemical Name:Benzonitrile, 2-[(3,4-dihydro-6-methoxy-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl)methyl]-
- CAS:2514763-78-9
- MF:C14H13N3O3
- Structure:
- Chemical Name:5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[(1E)-2-(4-methyl-5-thiazolyl)ethenyl]-8-oxo-7-[(2-phenylacetyl)amino]-, (4-methoxyphenyl)methyl ester, (6R,7R)-
- CAS:104146-11-4
- MF:C29H27N3O5S2
- Chemical Name:Dapagliflozin Impurity 46
- CAS:
- MF:
- Chemical Name:Brexpiprazole Impurity ABCDEFGHJKL
- CAS:
- MF:
- Structure:
- Chemical Name:p,p'-(2-pyridylmethylene)bisphenol
- CAS:603-41-8
- MF:C18H15NO2
- Structure:
- Chemical Name:O-Desmethyl Gefitinib
- CAS:847949-49-9
- MF:C21H22ClFN4O3
- Structure:
- Chemical Name:Pyrazole N-Demethyl Sildenafil
- CAS:139755-95-6
- MF:C21H28N6O4S
- Structure:
- Chemical Name:S-(-)-Tolterodine
- CAS:124937-53-7
- MF:C22H31NO
- Structure:
- Chemical Name:Zolmitriptan N-Oxide
- CAS:251451-30-6
- MF:C16H21N3O3
- Chemical Name:3-(hydroxymethyl)-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one
- CAS:
- MF:
- Structure:
- Chemical Name:17alpha-Hydroxytrenbolone
- CAS:80657-17-6
- MF:C18H22O2
- Chemical Name:Oseltamivir Impurity 125
- CAS:
- MF:
- Chemical Name:Oseltamivir Impurity 115
- CAS:
- MF:
- Chemical Name:Avatrombopag Impurity 70
- CAS:
- MF:
- Structure:
- Chemical Name:3,4-dihydroxybutanoic acid
- CAS:1518-61-2
- MF:C4H8O4
- Structure:
- Chemical Name:Isocyclosporin A
- CAS:59865-16-6
- MF:C62H111N11O12
- Chemical Name:GINKGOLIC ACIDS
- CAS:
- MF:
- Structure:
- Chemical Name:R-DULOXETINE HYDROCHLORIDE
- CAS:910138-96-4
- MF:C18H20ClNOS
- Structure:
- Chemical Name:diltiazem hydrochloride
- CAS:103532-27-0
- MF:C22H27ClN2O4S
- Structure:
- Chemical Name:(R)-Terazosin
- CAS:109351-34-0
- MF:C19H25N5O4
- Structure:
- Chemical Name:Methyl (1S,4R)-4-Amino-2-Cyclopentene-1-Carboxylate
- CAS:138923-03-2
- MF:C7H11NO2
- Structure:
- Chemical Name:L-Alanine,propylester(9CI)
- CAS:58989-06-3
- MF:C6H13NO2
- Chemical Name:Oprinone Impurity 4
- CAS:
- MF:
- Chemical Name:Mizolastine impurity C
- CAS:
- MF:
- Structure:
- Chemical Name:N-hydroxyphenetidine
- CAS:38246-95-6
- MF:
- Structure:
- Chemical Name:bergaptol-O-glucopyranoside
- CAS:131623-13-7
- MF:C17H16O9
- Structure:
- Chemical Name:PeraMpanel
- CAS:380919-34-6
- MF:C23H17N3O2
- Chemical Name:Empagliflozin Impurity 83
- CAS:
- MF:
- Structure:
- Chemical Name:Ambroxol Imp.O
- CAS:1807328-39-7
- MF:C13H12Br2N2O
- Structure:
- Chemical Name:Olopatadine Impurity 10 HBr
- CAS:4174-83-8
- MF:C22H26Br2NP
- Structure:
- Chemical Name:Octreotide (Dimer, Parallel)
- CAS:1926163-80-5
- MF:C98H132N20O20S4
- Chemical Name:Iohexol Impurity Q
- CAS:
- MF:
- Chemical Name:Avibactam sodium Impurity CIS
- CAS:
- MF:
- Structure:
- Chemical Name:Diphenidol Impurity 2
- CAS:63645-18-1
- MF:C16H17ClO
- Structure:
- Chemical Name:(2,5-dibromophenyl)(4-ethoxyphenyl)methanone
- CAS:1713015-63-4
- MF:C15H12Br2O2
- Chemical Name:Flucloxacillin Impurity 1
- CAS:
- MF:
- Chemical Name:Rocuronium Bromide Impurity 39
- CAS:
- MF:
- Structure:
- Chemical Name:Ticagrelor Intermediate 1 D-Tartrate
- CAS:2376278-72-5
- MF:C14H25NO10
- Structure:
- Chemical Name:2-(3,5-dicyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid
- CAS:2428631-65-4
- MF:C17H15N3O3S
- Structure:
- Chemical Name:Roxadustat impurity ZZ5
- CAS:
- MF:C17H12ClNO4
- Structure:
- Chemical Name:Lenvatinib impurity LFZZ-7
- CAS:
- MF:C11H9ClN2O2
- Chemical Name:Rosuvastatin Impurity 119
- CAS:
- MF:
- Chemical Name:Rosuvastatin Impurity 105
- CAS:
- MF:
- Structure:
- Chemical Name:(2R,3R,4R,5S,6R)-2-(acetoxymethyl)-6-(4-chloro-3-(4-(((S)-tetrahydrofuran-3-yl)oxy)benzyl)phenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate
- CAS:1620758-27-1
- MF:C31H35ClO11
- Chemical Name:Febuxostat Impurity 99
- CAS:
- MF:
- Chemical Name:Furosemide Impurity 20
- CAS:
- MF:
- Structure:
- Chemical Name:(3R,4R,5S)-ethyl 4,5-diacetamido-3-(pentan-3-yloxy)cyclohex-1- enecarboxylate
- CAS:1191921-01-3
- MF:C18H30N2O5
- Chemical Name:Ticagrelor Impurity 109
- CAS:
- MF:
- Chemical Name:Ticagrelor Impurity 134
- CAS:
- MF:
- Structure:
- Chemical Name:2-Propenamide, 2-cyano-3-(3,4-dihydroxyphenyl)-N,N-diethyl-, (2E)-
- CAS:1217439-96-7
- MF:C14H16N2O3
- Structure:
- Chemical Name:Benzonitrile, 4,4'-[[2,2'-bis(hydroxymethyl)[1,1'-biphenyl]-4,4'-diyl]bis(oxy)]bis-
- CAS:2254541-79-0
- MF:C28H20N2O4
- Structure:
- Chemical Name:Benzoic acid, 3-(butylamino)-5-[(butylamino)sulfonyl]-4-phenoxy-
- CAS:28469-01-4
- MF:C21H28N2O5S
- Structure:
- Chemical Name:Thailanstatin A
- CAS:1426953-21-0
- MF:C28H41NO9
- Structure:
- Chemical Name:Acetamide, N-[9-[[2-(acetyloxy)-1-(hydroxymethyl)ethoxy]methyl]-6,9-dihydro-6-oxo-1H-purin-2-yl]-
- CAS:298197-26-9
- MF:C13 H17 N5 O6
- Chemical Name:Topiroxostat Impurity 46
- CAS:
- MF:
- Chemical Name:Topiroxostat Impurity 43
- CAS:
- MF:
- Structure:
- Chemical Name:N-(2-(1-hydroxycyclohexyl)-2-(4-methoxyphenyl)ethyl)-N-methyl formamide
- CAS:1643948-40-6
- MF:C17H25NO3
- Chemical Name:Regorafenib Impurity 40
- CAS:
- MF:
- Structure:
- Chemical Name:3-Quinolinecarboxylic acid, 1-cyclopropyl-7-fluoro-1,4-dihydro-6,8-dimethoxy-4-oxo-, ethyl ester
- CAS:2489671-14-7
- MF:C17H18FNO5
- Structure:
- Chemical Name:Bisoprolol Impurity 17
- CAS:109791-19-7
- MF:C15H23NO5
- Structure:
- Chemical Name:Furosemide Impurity 5
- CAS:518336-22-6
- MF:C12H10ClNO3
- Structure:
- Chemical Name:Lumateperone Impurity 2
- CAS:313544-32-0
- MF:C16H19N3O3
- Structure:
- Chemical Name:Pramipexole Impurity 55
- CAS:959012-83-0
- MF:C8H11NO2
- Structure:
- Chemical Name:INDEX NAME NOT YET ASSIGNED
- CAS:2438857-80-6
- MF:C27H22F2N6O5
- Chemical Name:Nicergoline Impurity 01
- CAS:
- MF:
- Chemical Name:impurity 38
- CAS:
- MF:
- Chemical Name:Avatrombopag Impurity 23
- CAS:
- MF:
- Chemical Name:Avatrombopag Impurity 34
- CAS:
- MF:
- Chemical Name:Cisatracurium besylate impurity11
- CAS:
- MF:
- Structure:
- Chemical Name:Acetamide, N-?[4-?[5-?(acetylamino)?-?2-?hydroxyphenoxy]?phenyl]?-
- CAS:2575516-61-7
- MF:C16H16N2O4