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:
- (S)-Tamsulosin Hydrochloride
- CAS:
- 106463-19-8
- MF:
- C20H29ClN2O5S
- Structure:
- Chemical Name:
- 2,2'-Bisnalmefene
- CAS:
- 176220-84-1
- MF:
- C42H48N2O6
- Structure:
- Chemical Name:
- 4-Desmethoxypropoxyl-4-chloro Rabeprazole
- CAS:
- 168167-42-8
- MF:
- C14H12ClN3OS
- Structure:
- Chemical Name:
- N-Desmethyl-4-hydroxy Tamoxifen (approx. 1:1 E/Z Mixture)
- CAS:
- 110025-28-0
- MF:
- C25H27NO2
- Structure:
- Chemical Name:
- Rebeprazole sulfone N-oxide
- CAS:
- 924663-37-6
- MF:
- C18H21N3O5S
- Structure:
- Chemical Name:
- Benzeneethanamine, 4-nitro-N-(2-phenylethyl)-, hydrochloride (1:1)
- CAS:
- 1581285-28-0
- MF:
- C16H19ClN2O2
- Chemical Name:
- D-Glucopyranose, oligomeric, C8-10-alkyl glycosides
- CAS:
- 161074-97-1
- Chemical Name:
- Odaterol Impurity 34
- Structure:
- Chemical Name:
- Benzonitrile, 2-[(4-chloro-3,6-dihydro-2,6-dioxo-1(2H)-pyrimidinyl)methyl]-
- CAS:
- 2749357-07-9
- MF:
- C12H8ClN3O2
- Chemical Name:
- Odaterol Impurity 36
- Chemical Name:
- Odaterol Impurity 36
- Chemical Name:
- Odaterol Impurity 36
- Structure:
- Chemical Name:
- 4-nitro-1H-Imidazole-2-carboxaldehyde
- CAS:
- 33543-81-6
- MF:
- C4H3N3O3
- Structure:
- Chemical Name:
- 1-CHLOROMETHYL-2,3,4-TRIMETHOXYBENZENE
- CAS:
- 1133-49-9
- MF:
- C10H13ClO3
- Chemical Name:
- Bumetanide Impurity 19
- Chemical Name:
- Rocuronium Bromide Impurity 26 、27
- Chemical Name:
- Roxadustat Impurity 20
- Chemical Name:
- Ruxolitinib Impurity
- Structure:
- Chemical Name:
- 1-BOC-4-(5-NITRO-2-PYRIDYL)PIPERAZINE
- CAS:
- 193902-78-2
- MF:
- C14H20N4O4
- Chemical Name:
- Relugolix Impurity 25
- Chemical Name:
- Lumateperone Impurity 5
- Chemical Name:
- Sugammadex Sodium Impurity ORG139131-1
- Chemical Name:
- 2-[4-(Azidomethyl)phenyl]benzoic acid
- Structure:
- Chemical Name:
- 2-[(2-AZIDOETHOXY)METHYL]-4-(2-CHLOROPHENYL)-3-ETHOXYCARBONYL-5-METHOXYCARBONYL)-6-METHYL-1,4-DIHYDROPYRIDINE
- CAS:
- 88150-46-3
- MF:
- C20H23ClN4O5
- Chemical Name:
- ((6aR,9R,10aR)-7-methyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin-9-yl)methanol acetic acid salt
- Chemical Name:
- Brivaracetam Impurity 56
- Chemical Name:
- Oxytocin Impurity 3
- Chemical Name:
- Rosuvastatin Impurity 158
- Chemical Name:
- Rosuvastatin Impurity 139
- Chemical Name:
- Rosuvastatin Impurity 124
- Structure:
- Chemical Name:
- Hesperidin methylchalcone
- CAS:
- 24292-52-2
- MF:
- C29H36O15
- Structure:
- Chemical Name:
- Ethyl 5,6-dichloro-3,4-dihydro-2(1H)-iminoquinazoline-3-acetate hydrobromide
- CAS:
- 70381-75-8
- MF:
- C12H14BrCl2N3O2
- Structure:
- Chemical Name:
- 4-(3,4-Dichlorophenyl)-1,2,3,4-Tetrahydro-
- CAS:
- 79617-95-1
- MF:
- C17H17Cl2N
- Chemical Name:
- Avatrombopag Impurity 77
- Chemical Name:
- methyl 5-((4-(3-carbamoyl-1-(4-methoxyphenyl)-7-oxo-1,4,5,7-tetrahydro-6H-pyrazolo[3,4-c]pyridin-6-yl)phenyl)amino)pentanoate
- Chemical Name:
- N-(4-((3-chloro-4-fluorophenyl)amino)-7-fluoroquinazolin-6-yl)-4-(dimethylamino)butanamide
- Chemical Name:
- Ertapenem Impurity A(USP)
- Structure:
- Chemical Name:
- D-Glutamic acid, 4-(cyanomethyl)-N-[(1,1-dimethylethoxy)carbonyl]-, 1,5-dimethyl ester, (4S)-rel-
- CAS:
- 2740644-40-8
- MF:
- C14H22N2O6
- Structure:
- Chemical Name:
- INDEX NAME NOT YET ASSIGNED
- CAS:
- 2731089-65-7
- MF:
- C27H34N2O6
- Chemical Name:
- 2-(2-ethoxy-3-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one
- Chemical Name:
- Bumetanide Photodegradable Impurity 15
- Chemical Name:
- Bisoprolol Impurity 48
- Chemical Name:
- Sitagliptin Impurity 82
- Chemical Name:
- Perospirone Impurity 21
- Chemical Name:
- Perospirone Impurity 11
- Chemical Name:
- Dolutegravir Impurity 21
- Chemical Name:
- NA
- Chemical Name:
- Fondaparinux sodium impurity 7
- Chemical Name:
- Fondaparinux sodium impurity 3
- Chemical Name:
- Oxacillin sodium Impurity B
- Chemical Name:
- Revefenacin Impurity 21
- Chemical Name:
- Canagliflozin Impurity 33
- Structure:
- Chemical Name:
- Loratadine Impurity 14
- CAS:
- 169253-13-8
- MF:
- C22H23ClN2O2
- Structure:
- Chemical Name:
- Metronidazole Impurity 3
- CAS:
- 5006-79-1
- MF:
- C6H7N3O2
- Structure:
- Chemical Name:
- Nifedipine Impurity 9
- CAS:
- 87625-92-1
- MF:
- C15H15NO5
- Structure:
- Chemical Name:
- Peramivir Impurity 7 HCl
- CAS:
- 1352062-19-1
- MF:
- C14H27ClN2O4
- Structure:
- Chemical Name:
- Butylphthalide impurity
- CAS:
- 380905-48-6
- MF:
- C12H16O3
- Structure:
- Chemical Name:
- Dapoxetine impurity
- CAS:
- 2242008-38-2
- MF:
- C30H32ClNO2
- Structure:
- Chemical Name:
- Esomeprazole Impurity 26
- CAS:
- 704910-88-3
- MF:
- C15H15N3OS
- Chemical Name:
- Pregabalin Impurity 25
- Structure:
- Chemical Name:
- Loxoprofen
- CAS:
- 50882-18-3
- MF:
- C7H10O3
- Structure:
- Chemical Name:
- Ropivacaine impurity
- CAS:
- 1543937-58-1
- MF:
- C13H16N2O3
- Structure:
- Chemical Name:
- Mono Oxidation Sugammadex(Org198958-2)
- CAS:
- 2412953-13-8
- MF:
- C72H113NaO49S8
- Structure:
- Chemical Name:
- 3,3'-(oxybis(ethane-1,1-diyl))bis(1,2-dimethylbenzene)
- MF:
- C20H26O
- Chemical Name:
- Piperacillin Impurity 4
- Structure:
- Chemical Name:
- (R)-3-amino-4-phenyl-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4] triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one
- CAS:
- 2749805-70-5
- MF:
- C16H18F3N5O
- Structure:
- Chemical Name:
- Amlodipine Impurity 30
- CAS:
- 95574-97-3
- MF:
- C4H7ClO3
- Chemical Name:
- Axitinib Impurity 24
- Structure:
- Chemical Name:
- Rasagiline Impurity 3
- CAS:
- 1175018-74-2
- MF:
- C12H14ClN
- Structure:
- Chemical Name:
- (+/-)-EPINEPHRINE SULFONIC ACID
- CAS:
- 26405-77-6
- MF:
- C9H13NO5S
- Structure:
- Chemical Name:
- GADOTERIDOL RELATED COMPOUND B (50 MG) (1,4,7,10-TETRAAZACYCLODODECANE-1,4,7-TRIACETIC ACID, MONOGADOLINIUM SALT)
- CAS:
- 112188-16-6
- MF:
- C14H22GdN4O6
- Structure:
- Chemical Name:
- 4-tert-Butyl-N-(6-chloro-5-(2-methoxyphenoxy)-2,2'-bipyrimidin-4-yl)benzenesulfonamide
- CAS:
- 150727-06-3
- MF:
- C25H24ClN5O4S
- Structure:
- Chemical Name:
- (S)-2-(BENZYLOXY)PROPIONAL
- CAS:
- 81445-44-5
- MF:
- C10H12O2
- Structure:
- Chemical Name:
- 1-Chloro-2-[(4-ethoxyphenyl)methyl]benzene
- CAS:
- 1662702-90-0
- MF:
- C15H15ClO
- Structure:
- Chemical Name:
- Mupirocin iMpurity F
- MF:
- C26H44O9
- Structure:
- Chemical Name:
- Palbociclib Impurity 87
- CAS:
- 571189-51-0
- MF:
- C25H31N7O2
- Chemical Name:
- Beclometasone Impurity U
- Structure:
- Chemical Name:
- Atracurium Impurity 15 Iodide（Cisatracurium Besilate EP Impurity O Iodide）
- CAS:
- 155913-31-8
- MF:
- C38H49NO11S
- Structure:
- Chemical Name:
- Vortioxetine Impurity 29
- CAS:
- 1928741-88-1
- MF:
- C18H23ClN2S
- Structure:
- Chemical Name:
- Neratinib Impurity 12
- CAS:
- 544417-27-8
- MF:
- C33H37ClN6O3
- Chemical Name:
- Ceftriaxone Sodium impurity 2
- Structure:
- Chemical Name:
- Enrofloxacin EP Impurity E
- CAS:
- 1369495-59-9
- MF:
- C19H22ClN3O3
- Structure:
- Chemical Name:
- 147027-08-5
- CAS:
- 147027-08-5
- MF:
- C14H24O4S
- Structure:
- Chemical Name:
- Cloxacillin EP Impurity A
- CAS:
- 1642629-96-6
- MF:
- C19H20ClN3O6S
- Structure:
- Chemical Name:
- Entacapone Impurity 7
- CAS:
- 1215039-66-9
- MF:
- C12H10N2O6
- Structure:
- Chemical Name:
- 1,8-dibenzyl-1,4,8,11-tetraazacyclotetradecane tetrahydrochloride
- CAS:
- 267241-20-3
- MF:
- C24H37ClN4
- Structure:
- Chemical Name:
- (3S,3'S,4R,4'R)-3,3'-(oxybis(methylene))bis(4-(4-fluorophenyl)-1- methylpiperidine)
- MF:
- C26H34F2N2O
- Chemical Name:
- DexMedetoMidine IMpurity 15
- Chemical Name:
- Canagliflozin Impurity 1
- Chemical Name:
- Vonoprazan Impurity 24
- Chemical Name:
- Esomeprazole Impurity
- Chemical Name:
- Esomeprazole Impurity 27
- Structure:
- Chemical Name:
- Amlodipine Impurity 30
- CAS:
- 1089674-39-4
- MF:
- C26H31ClN2O8S
- Chemical Name:
- Alogliptin Impurity 30
- Chemical Name:
- Orlistat Impurity 16
- Chemical Name:
- Olaparib Impurity 27
- Structure:
- Chemical Name:
- Hydrocortisone Impurity 14
- MF:
- C21H30O5