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:Umeclidinium Impurity 3
- CAS:869113-45-1
- MF:C29H32BrNO3
- Structure:
- Chemical Name:Vardenafil Impurity 7
- CAS:448184-56-3
- MF:C21H26N6O7S
- Structure:
- Chemical Name:Moxifloxacin Related Compound A (HCl salt form)
- CAS:151282-23-4
- MF:C20H22ClF2N3O3
- Structure:
- Chemical Name:8-Hydroxy Entecavir
- CAS:1795791-10-4
- MF:C12H15N5O4
- Structure:
- Chemical Name:1-Pyrrolidinecarboxylic acid, 4-[4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)-1-piperazinyl]-2-(3-thiazolidinylcarbonyl)-, 1,1-dimethylethyl ester, (2S,4R)-
- CAS:1404559-22-3
- MF:C27H38N6O3S
- Chemical Name:Ampicillin Impurity A
- CAS:
- MF:
- Chemical Name:Cefditoren Pivoxil Dimer
- CAS:
- MF:
- Chemical Name:Cefixime Impurity A(EP)
- CAS:
- MF:
- Chemical Name:Oxacillin Sodium Impurity B(EP)
- CAS:
- MF:
- Structure:
- Chemical Name:3,5-dichlorothiophene-2-carboxylic acid
- CAS:89166-94-9
- MF:C5H2Cl2O2S
- Structure:
- Chemical Name:Brexpiprazole Impurity 2
- CAS:2094559-58-5
- MF:C38H40N4O4S
- Structure:
- Chemical Name:2-methyl-6-oxo-1,6-dihydro-[3,4'-bipyridine]-5-carboxylic acid
- CAS:80047-38-7
- MF:C12H10N2O3
- Structure:
- Chemical Name:Levofloxacin Impurity 7
- CAS:1607796-83-7
- MF:C15H14FNO5
- Chemical Name:Moxifloxacin EP Impurity E HCl
- CAS:
- MF:
- Structure:
- Chemical Name:Pantoprazole Impurity 11
- CAS:172282-50-7
- MF:C7H8F2N2O
- Structure:
- Chemical Name:Solifenacin Related Compound 24
- CAS:1682642-69-8
- MF:C15H23ClN2
- Structure:
- Chemical Name:Ticagrelor Related Compound 44
- CAS:1431867-40-1
- MF:C8H12ClN3OS
- Structure:
- Chemical Name:(trans)-2-(3,4-difluorophenyl)cyclopropanecarboxamide
- CAS:1006614-51-2
- MF:C10H9F2NO
- Structure:
- Chemical Name:1-(4-(2-methyl-6-oxopiperidin-1-yl)phenyl)-3-morpholino-5,6-dihydropyridin-2(1H)-one
- CAS:2098457-93-1
- MF:C21H27N3O3
- Structure:
- Chemical Name:5-ethyl 3-isopropyl 2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
- CAS:2170716-02-4
- MF:C22H29ClN2O5
- Structure:
- Chemical Name:Acetamide,N-(2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl)-
- CAS:6118-65-6
- MF:C10H8N2O3
- Chemical Name:Ibrutinib impurity D
- CAS:
- MF:
- Structure:
- Chemical Name:Mupirocin impurity A
- CAS:
- MF:C26H44O9
- Structure:
- Chemical Name:Aurantio-obtusin-6-O-β-D-glucoside
- CAS:129025-96-3
- MF:C23H24O12
- Structure:
- Chemical Name:FG-4592 intermediate7
- CAS:1509958-19-3
- MF:C20H20N2O4
- Structure:
- Chemical Name:Milnacipran Impurity 13
- CAS:710339-49-4
- MF:C12H16NO+
- Chemical Name:Ofloxacin/Levofloxacin Impurity A
- CAS:
- MF:
- Chemical Name:Urapidil Impurity A
- CAS:
- MF:
- Chemical Name:Tofacitinib Impurity I
- CAS:
- MF:
- Structure:
- Chemical Name:34-Methylcyanocobalamin
- CAS:38218-51-8
- MF:C64H90CoN14O14P
- Chemical Name:Empagliflozin Impurity D
- CAS:
- MF:
- Chemical Name:Ipragliflozin Impurity 2
- CAS:
- MF:
- Chemical Name:Nicergoline EP impurity F
- CAS:
- MF:
- Chemical Name:Mirabegron Impurity 4
- CAS:
- MF:
- Structure:
- Chemical Name:Bisoprolol EP Impurity D
- CAS:1225195-71-0
- MF:C26H40N2O5
- Structure:
- Chemical Name:Febuxostat Descyano Impurity
- CAS:1206550-99-3
- MF:C15H17NO3S
- Structure:
- Chemical Name:(5S,8R,9S,10S,13S,14S)-10,13-dimethyl-1,5,6,7,8,9,10,11,12,13,15,16-dodecahydro-4H-cyclopenta[a]phenanthren-17(14H)-one
- CAS:14639-79-3
- MF:C19H28O
- Structure:
- Chemical Name:Cefuroxime Sodium Impurity
- CAS:
- MF:C16H16N4NaO8S
- Structure:
- Chemical Name:5-chloro-6-[4-(ethoxycarbonyl)piperidino]nicotinic acid
- CAS:931395-73-2
- MF:C14H17ClN2O4
- Structure:
- Chemical Name:2-Bromo (S)-Carbidopa
- CAS:43197-33-7
- MF:C10H13BrN2O4
- Structure:
- Chemical Name:Eliglustat intermediate 3
- CAS:491833-26-2
- MF:C23H28N2O5
- Structure:
- Chemical Name:Aztreonam Impurity B
- CAS:102586-36-7
- MF:C13H19N5O6S
- Structure:
- Chemical Name:Atorvastatin Impurity 30
- CAS:666714-64-3
- MF:C26H23FN2O
- Chemical Name:Olopatadine impurity
- CAS:
- MF:
- Structure:
- Chemical Name:Azilsartan Impurity
- CAS:1863930-34-0
- MF:C23H23N3O3
- Structure:
- Chemical Name:Voriconazole Impurity 8
- CAS:239807-03-5
- MF:C16H14F3N5O
- Chemical Name:Caspofungin impurity 3
- CAS:
- MF:
- Structure:
- Chemical Name:2-cyano-N-methyl-N-((3R,4R)-4-methyl piperidin-3-yl) Acetamide hydrochloride
- CAS:1640971-87-4
- MF:C10H18ClN3O
- Structure:
- Chemical Name:6-methyl-N1-(4-methyl-6-(pyridin-3-yl)pyrimidin-2-yl)benzene-1,3-diamine
- CAS:
- MF:C17H17N5
- Structure:
- Chemical Name:5-METHOXY-2-BENZIMIDAZOLINONE
- CAS:2080-75-3
- MF:C8H8N2O2
- Structure:
- Chemical Name:WPDCFRNNHUYQGW-IUXPMGMMSA-N
- CAS:1628639-06-4
- MF:C21H23NO4
- Structure:
- Chemical Name:tert-Butyl 2-((4S,6S)-6-(chloromethyl(02,2-1,3-dioxan-4-yl)acetate
- CAS:521974-00-5
- MF:C13H23ClO4
- Structure:
- Chemical Name:Cefadroxil Sulfoxide
- CAS:182290-77-3
- MF:C16H17N3O6S
- Structure:
- Chemical Name:GSFIWDGFHNAUFU-UHFFFAOYSA-N
- CAS:2125702-80-7
- MF:C16H29N5O4
- Structure:
- Chemical Name:7-Methoxy-4-oxo-1,4-dihydroquinoline-6-carboxaMide
- CAS:417724-81-3
- MF:C11H10N2O3
- Chemical Name:Tegafur Impurity BCB
- CAS:
- MF:
- Structure:
- Chemical Name:(R)-diethyl 2-(4-(3-chloro-4-fluorophenylaMino)-7-(tetrahydrofuran-3-yloxy)quinazolin-6-ylaMino)-2-oxo
- CAS:618061-77-1
- MF:C24H27ClFN4O6P
- Structure:
- Chemical Name:((2R,3R,4R)-3-(benzoyloxy)-4-chloro-4-Methyl-5-oxotetrahydrofuran-2-yl)Methyl benzoate
- CAS:1496551-65-5
- MF:C20H17ClO6
- Structure:
- Chemical Name:2-(4-fluorophenyl)-5-(2-Methylbenzyl)thiophene
- CAS:2005454-69-1
- MF:C18H15FS
- Structure:
- Chemical Name:AcetaMide, N-[[(5S)-2-oxo-3-[4-(3-oxo-4-Morpholinyl)phenyl]-5-oxazolidinyl]Methyl]-
- CAS:1429334-00-8
- MF:C16H19N3O5
- Structure:
- Chemical Name:PSI 7411
- CAS:1015073-43-4
- MF:C10H14FN2O8P
- Structure:
- Chemical Name:5-[[4-(Hydroxymethyl)phenoxy]methyl]-3-(1-methylethyl)-2-oxazolidinone
- CAS:1071765-44-0
- MF:C14H19NO4
- Structure:
- Chemical Name:(1S)-1,5-Anhydro-1-C-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol 2,3,4,6-tetrakis(2,2-dimethylpropanoate)
- CAS:1283129-18-9
- MF:C44H57FO9S
- Structure:
- Chemical Name:[1,4'-Bipiperidine]-1'-carboxylic acid
- CAS:1026078-50-1
- MF:C11H20N2O2
- Structure:
- Chemical Name:4-[[3-(1-Methylethyl)-2-oxo-5-oxazolidinyl]methoxy]benzaldehyde
- CAS:1173203-26-3
- MF:C14H17NO4
- Chemical Name:EMpagliflozin iMpurity 9
- CAS:
- MF:
- Structure:
- Chemical Name:EMpagliflozin iMpurity 14
- CAS:2137418-13-2
- MF:C23H27ClO8
- Structure:
- Chemical Name:570403-04-2
- CAS:570403-04-2
- MF:C23H24Cl3N5OS2
- Chemical Name:ibrutinib iMpurity A
- CAS:
- MF:
- Chemical Name:Sunitinib iMpurity E
- CAS:
- MF:
- Structure:
- Chemical Name:Rosuvastatin EP impurity H
- CAS:1335110-44-5
- MF:C22H28FN3O6S
- Chemical Name:Saxagliptin Impurity 4 (Deoxy Saxagliptin)
- CAS:
- MF:
- Structure:
- Chemical Name:Betamethasone EP Impurity D
- CAS:52619-05-3
- MF:C25H33FO7
- Structure:
- Chemical Name:Dihydropenicillin F Potassium Salt
- CAS:31447-86-6
- MF:C14H23KN2O4S
- Structure:
- Chemical Name:Etoricoxib Impurity 7
- CAS:646459-39-4
- MF:C20H21N3O2S
- Structure:
- Chemical Name:Mupirocin Impurity D
- CAS:
- MF:C26H44O9
- Structure:
- Chemical Name:Pazopanib Related Compound 2
- CAS:1226500-02-2
- MF:C26H23ClN10
- Structure:
- Chemical Name:Phenylephrine EP Impurity D
- CAS:1367567-95-0
- MF:C16H19NO2
- Structure:
- Chemical Name:Verapamil Impurity O
- CAS:959011-16-6
- MF:C27H38N2O4
- Structure:
- Chemical Name:1,1′-[(1-Methylethyl)imino]bis[3-[4-(2-methoxyethyl)phenoxy]-2-propanol hydrochloride
- CAS:1486464-40-7
- MF:C27H42ClNO6
- Structure:
- Chemical Name:(Z)-2-(2-Aminothiazol-4-yl)-2-(1-carboxy-1-methyl)ethoxyiminoacetic acid
- CAS:102507-85-7
- MF:C9H11N3O5S
- Chemical Name:Cefaclor EP IMpurity
- CAS:
- MF:
- Structure:
- Chemical Name:Alogliptin Impurity B
- CAS:865758-98-1
- MF:C17H19N5O2
- Structure:
- Chemical Name:Alogliptin Impurity B
- CAS:865758-98-1
- MF:C17H19N5O2
- Structure:
- Chemical Name:Linagliptin Impurity F
- CAS:1673546-62-7
- MF:C27H27F3N8O3
- Chemical Name:Plerixafor Impurity D
- CAS:
- MF:
- Structure:
- Chemical Name:Cefuroxime impurity 1
- CAS:
- MF:C16H16N4O8S
- Chemical Name:Vonoprazan Impurity 9
- CAS:
- MF:
- Chemical Name:Sitagliptin IMpurity 5
- CAS:
- MF:
- Chemical Name:Brexpiprazole Impurity3
- CAS:
- MF:
- Structure:
- Chemical Name:Levetiracetam impurity 5
- CAS:1543300-90-8
- MF:C9H17NO4
- Chemical Name:Febuxostat Impurity B
- CAS:
- MF:
- Chemical Name:Sorafenib Impurity F
- CAS:
- MF:
- Structure:
- Chemical Name:Trelagliptin Impurity 1
- CAS:1821400-07-0
- MF:C21H13ClF2N4O2
- Structure:
- Chemical Name:Vortioxetine Imp.J
- CAS:2137588-68-0
- MF:C18H22N2S
- Structure:
- Chemical Name:4-amino-N-(1-(3-methoxypropyl)piperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide
- CAS:1608459-56-8
- MF:C18H27N3O3
- Structure:
- Chemical Name:4,5-dichloro Rivaroxaban
- CAS:2305917-61-5
- MF:C25H28ClN3O6S
- Structure:
- Chemical Name:Solifenacin EP Impurity B
- CAS:1534326-81-2
- MF:C31H28N2O
- Structure:
- Chemical Name:Vildagliptin Impurity 6
- CAS:1846606-31-2
- MF:C17H23N3O2
- Chemical Name:Flucloxacillin Impurity A
- CAS:
- MF: