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:
- 1-((2'-cyanobiphenyl-4-yl)methyl)-4-methyl-2-propyl-1H-benzo[d]imidazole-6-carboxylic acid
- CAS:
- 1098100-87-8
- MF:
- C26H23N3O2
- Chemical Name:
- Fimasartan Impurity
- Structure:
- Chemical Name:
- 2-(((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)methyl)(methyl)amino)succinic acid
- MF:
- C21H20FN3O6S
- Structure:
- Chemical Name:
- ()-Olivil 4″-O-glucoside
- CAS:
- 76880-93-8
- MF:
- C26H34O12
- Structure:
- Chemical Name:
- 2-(DIETHYLAMINO)-N-(2,4-DIMETHYLPHENYL)ACETAMIDE
- CAS:
- 17289-53-1
- MF:
- C14H22N2O
- Structure:
- Chemical Name:
- (R)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one
- CAS:
- 1612153-32-8
- MF:
- C20H20FNO4
- Structure:
- Chemical Name:
- (S)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one
- CAS:
- 528565-93-7
- MF:
- C20H20FNO4
- Chemical Name:
- Posaconazole iMpurity 3
- Structure:
- Chemical Name:
- 7-Methoxy-4-oxo-1,4-dihydroquinoline-6-carboxylic acid
- CAS:
- 417721-34-7
- MF:
- C11H9NO4
- Chemical Name:
- Pemetrexed
- Structure:
- Chemical Name:
- Venlafaxine
- MF:
- C17H27NO2
- Structure:
- Chemical Name:
- (S)-4,5-dichloro-N-((2-oxo-3-(4-(3-oxoMorpholino)phenyl)oxazolidin-5-yl)Methyl)thiophene-2-carboxaMide
- CAS:
- 1770812-37-7
- MF:
- C19H17Cl2N3O5S
- Structure:
- Chemical Name:
- 2-Propen-1-one, 1-[4-[4-aMino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyriMidin-1-yl]-1-piperidinyl]-
- CAS:
- 936563-92-7
- MF:
- C25H24N6O2
- Structure:
- Chemical Name:
- 8-cyclopentyl-5-Methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)aMino)-6-vinylpyrido[2,3-d]pyriMidin-7(8H)-one
- MF:
- C24H29N7O
- Structure:
- Chemical Name:
- D-Alanine, N-[[P(R),2'R]-2'-deoxy-2'-fluoro-2'-Methyl-P-phenyl-5'-uridylyl]-, 1-Methylethyl ester
- CAS:
- 1496552-16-9
- MF:
- C22H29FN3O9P
- Structure:
- Chemical Name:
- D-Phenylalanine, N-[(1,1-diMethylethoxy)carbonyl]-L-leucyl-, Methyl ester
- CAS:
- 15136-32-0
- MF:
- C21H32N2O5
- Structure:
- Chemical Name:
- 4-Nitro-2-phenoxyphenol
- CAS:
- 70995-08-3
- MF:
- C12H9NO4
- Structure:
- Chemical Name:
- Sofosbuvir Impurity
- CAS:
- 1233335-82-4
- MF:
- C16H25FN3O9P
- Structure:
- Chemical Name:
- Ethyl 3,4-O-isopropylideneshikiMate
- CAS:
- 136994-78-0
- MF:
- C12H18O5
- Structure:
- Chemical Name:
- 4-Vinyl-piperidine-4-carboxylic acid ethyl ester
- CAS:
- 1509910-91-1
- MF:
- C10H17NO2
- Structure:
- Chemical Name:
- (2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoic acid
- CAS:
- 1039307-95-3
- MF:
- C18H21NO2
- Chemical Name:
- EMpagliflozin iMpurity 16
- Structure:
- Chemical Name:
- ((R)-2-biphenyl-4-yl-1-forMylethyl)carbaMic acid t-butyl ester
- CAS:
- 149709-58-0
- MF:
- C20H23NO3
- Structure:
- Chemical Name:
- 1-(2,3-DiMethylphenyl)-1-(1H-iMidazol-4-yl)ethanol
- CAS:
- 86347-12-8
- MF:
- C13H16N2O
- Chemical Name:
- Oxaliplatin impurity
- Structure:
- Chemical Name:
- NiMesulide EP IMpurity
- CAS:
- 38880-53-4
- MF:
- C7H8N2O5S
- Structure:
- Chemical Name:
- Alogliptin Impurity D
- CAS:
- 1926163-25-8
- MF:
- C61H86N16O13
- Chemical Name:
- Moxifloxacin Impurities
- Structure:
- Chemical Name:
- Parecoxib Impurity K
- CAS:
- 198471-69-1
- MF:
- C17H16N2O3S
- Structure:
- Chemical Name:
- Linagliptin Impurity K
- CAS:
- 1638744-06-5
- MF:
- C25H29BrN8O2
- Structure:
- Chemical Name:
- (R)-2-((6-(3-((3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)amino)piperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile
- CAS:
- 1917324-13-0
- MF:
- C31H28F2N8O4
- Structure:
- Chemical Name:
- L-Phenylalanine, N-[(5,7-dichloro-1,2,3,4-tetrahydro-6-isoquinolinyl)carbonyl]-3-(methylsulfonyl)-, phenylmethyl ester, hydrochloride (1:1)
- CAS:
- 1194550-65-6
- MF:
- C27H27Cl3N2O5S
- Structure:
- Chemical Name:
- Alogliptin Related Compound 23
- CAS:
- 1618644-29-3
- MF:
- C20H13ClN4O2
- Chemical Name:
- Etoricoxib Impurity 14
- Chemical Name:
- Riociguat Impurtiy 3
- Chemical Name:
- Trelagliptin Impurity 2
- Structure:
- Chemical Name:
- Chlorhexidine Impurity B
- CAS:
- 1308292-89-8
- MF:
- C16H26ClN9O
- Chemical Name:
- Dapoxetine Impurity D
- Chemical Name:
- Eltrombopag Impurity 5
- Structure:
- Chemical Name:
- Exemestane Impurity 1
- CAS:
- 159354-61-7
- MF:
- C20H24O3
- Structure:
- Chemical Name:
- Lidocaine Impurity
- CAS:
- 35891-84-0
- MF:
- C11H16N2O.ClH
- Chemical Name:
- Pramipexole Impurity J
- Chemical Name:
- Rosuvastatin EP Impurity B (Sodium Salt)
- Structure:
- Chemical Name:
- Solifenacin Related Compound 14
- CAS:
- 605696-10-4
- MF:
- C25H30N2O2
- Structure:
- Chemical Name:
- 4-amino-1-((2R,3R,5S)-2-(hydroxymethyl)-3-oxido-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one
- CAS:
- 160552-54-5
- MF:
- C8H11N3O4S
- Structure:
- Chemical Name:
- 1-(4-Hydroxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide
- CAS:
- 503612-76-8
- MF:
- C24H23N5O4
- Structure:
- Chemical Name:
- 8-[(1R)-1-Hydroxy-2-[[2-(4-methoxyphenyl)-1,1-dimethylethyl]amino]ethyl]-6-(phenylmethoxy)-2H-1,4-benzoxazin-3(4H)-one
- CAS:
- 869478-13-7
- MF:
- C28H32N2O5
- Structure:
- Chemical Name:
- 1-(2-(methylamino)ethyl)piperidin-4-yl [1,1'-biphenyl]-2-ylcarbamate
- CAS:
- 743460-48-2
- MF:
- C21H27N3O2
- Structure:
- Chemical Name:
- Cefuroxime Sodium impurity D
- MF:
- C16H16N4NaO8S
- Chemical Name:
- Silodosin impurity A
- Chemical Name:
- cefditoren △-3 isomer
- Structure:
- Chemical Name:
- Ixazomib Impurity 1
- CAS:
- 1201903-02-7
- MF:
- C24H33BCl2N2O4
- Chemical Name:
- Ofloxacin/Levofloxacin Impurity E
- Structure:
- Chemical Name:
- (3S)-9,10-difluoro-3-methyl-7-oxo-2,3,6,7-tetrahydro-5H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid
- CAS:
- 1026952-91-9
- MF:
- C13H11F2NO4
- Structure:
- Chemical Name:
- (3RS)-3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one
- MF:
- C16H20N2O
- Structure:
- Chemical Name:
- ((4-Methoxyphenoxy)methylene)dibenzene
- CAS:
- 85686-16-4
- MF:
- C20H18O2
- Chemical Name:
- Tofacitinib Impurity L
- Structure:
- Chemical Name:
- 1-chloro-3-(dimethoxymethyl)benzene
- CAS:
- 3395-80-0
- MF:
- C9H11ClO2
- Structure:
- Chemical Name:
- N-(3-bromo-4-oxocyclohexyl)acetamide
- CAS:
- 687639-03-8
- MF:
- C8H12BrNO2
- Structure:
- Chemical Name:
- methyl (Z)-3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylate
- MF:
- C44H51N9O4
- Chemical Name:
- Alvimopan Impurity 5
- Structure:
- Chemical Name:
- Palbociclib-d8
- CAS:
- 1628752-83-9
- MF:
- C24H21D8N7O2
- Structure:
- Chemical Name:
- Ivabradine Impurity 15
- CAS:
- 1132667-04-9
- MF:
- C12H17NO2
- Chemical Name:
- Sofosbuvir Impurity27
- Chemical Name:
- Isavuconazole Impurity 12
- Structure:
- Chemical Name:
- Tacrolimus Impurity 3
- CAS:
- 161861-10-5
- MF:
- C45H71NO13
- Structure:
- Chemical Name:
- Aprepitant EP Impurity C
- CAS:
- 2208275-99-2
- MF:
- C29H25F7N4O3
- Structure:
- Chemical Name:
- Bisoprolol EP Impurity J
- CAS:
- 1797024-50-0
- MF:
- C15H24O5
- Structure:
- Chemical Name:
- Ceftriaxone Impurity
- CAS:
- 79221-95-7
- MF:
- C18H18N8O8S3
- Structure:
- Chemical Name:
- Betaxolol EP Impurity E
- CAS:
- 1329613-85-5
- MF:
- C18H31NO3
- Structure:
- Chemical Name:
- Tulobuterol Impurity
- CAS:
- 34356-83-7
- MF:
- C8H5Br2ClO
- Chemical Name:
- Olaparib Impurity A
- Chemical Name:
- Dapoxetine Impurity 2
- Chemical Name:
- Voriconazole Impurity 5
- Structure:
- Chemical Name:
- tetrahydrofuran-3-yl 2-cyclopentyl-2-hydroxy-2-phenylacetate
- CAS:
- 1404453-75-3
- MF:
- C17H22O4
- Chemical Name:
- Lamivudine impurity 5
- Structure:
- Chemical Name:
- Clopidogrel Impurity 2
- MF:
- C15H14ClNO2S
- Structure:
- Chemical Name:
- Mirabegron Impurity 6
- CAS:
- 2762802-64-0
- MF:
- C10H11ClN4O3S2
- Chemical Name:
- Pitavastatin Impurity 3
- Chemical Name:
- Solifenacin EP Impurity D
- Structure:
- Chemical Name:
- Cephalexin Impurity 2
- MF:
- C16H17N3O4S
- Structure:
- Chemical Name:
- Cefuroxime Impurity 3
- MF:
- C16H16N4O8S
- Chemical Name:
- Vonoprazan Impurity 11
- Chemical Name:
- Atracurium Impurity A
- Chemical Name:
- Erlotinib Imp.14
- Structure:
- Chemical Name:
- Sorafenib related compound 12
- CAS:
- 284461-74-1
- MF:
- C20H14ClF3N4O3
- Structure:
- Chemical Name:
- Apremilast Impurity 10
- CAS:
- 1809170-71-5
- MF:
- C22H26N2O8S
- Structure:
- Chemical Name:
- (1R,3S)-Solifenacin Succinate
- CAS:
- 774517-20-3
- MF:
- C23H26N2O2
- Chemical Name:
- Dacpomycin Impurity 2
- Chemical Name:
- Nicorandil Impurity 3
- Structure:
- Chemical Name:
- 1,2,4-Triazolo(3,4-b)benzothiazole-5-methanol
- CAS:
- 69243-49-8
- MF:
- C9H7N3OS
- Structure:
- Chemical Name:
- Benzoicacid, 2-sulfino-
- CAS:
- 13165-80-5
- MF:
- C7H6O4S
- Structure:
- Chemical Name:
- Benzenemethanamine, a-ethyl-N,N-dimethyl-
- CAS:
- 3330-05-0
- MF:
- C11H17N
- Structure:
- Chemical Name:
- 4-Chloro-2-fluoro-N-methylbenzamide
- CAS:
- 1343038-33-4
- MF:
- C8H7ClFNO
- Structure:
- Chemical Name:
- N-FORMYL-1-(2-AMINO-1-(4-METHOXYPHENYL)ETHYL)CYCLOHEXANOL
- CAS:
- 272788-07-5
- MF:
- C16H23NO3
- Structure:
- Chemical Name:
- 2-(7-methoxy-3,4-dihydronaphthalen-1-yl)ethan-1-amine
- CAS:
- 1353100-18-1
- MF:
- C13H18ClNO
- Structure:
- Chemical Name:
- Acotiamide Impurity
- CAS:
- 198470-83-6
- MF:
- C20H21N2NaO4S
- Structure:
- Chemical Name:
- Terbutaline Impurity
- CAS:
- 52144-90-8
- MF:
- C26H29NO3
- Structure:
- Chemical Name:
- methyl (41S,12R,13aR)-13a-ethyl-12- hydroxy-2,3,41,5,6,12,13,13aoctahydro- 1H-indolo[3,2,1- de]pyrido[3,2,1-ij][1,5]naphthyridine- 12-carboxylate
- CAS:
- 83508-83-2
- MF:
- C21H26N2O3
- Structure:
- Chemical Name:
- ethyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate
- CAS:
- 473465-11-1
- MF:
- C18H18N2O3S