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,R,S,S)-Orlistat
- CAS:
- 111466-63-8
- MF:
- C29H53NO5
- Structure:
- Chemical Name:
- 2'-Nor ThiaMine
- CAS:
- 7770-93-6
- MF:
- C11H15ClN4OS
- Structure:
- Chemical Name:
- 2-Amino-4-trifluoromethoxybenzothiazole
- CAS:
- 235101-36-7
- MF:
- C8H5F3N2OS
- Structure:
- Chemical Name:
- 7-[(4S)-4-Amino-6-azaspiro[2.4]heptan-6-yl]-8-chloro-6-fluoro-1-[(1R,2S)-2-fluorocyclopropyl]-4-oxoquinoline-3-carboxylic acid
- CAS:
- 127254-10-8
- MF:
- C19H18ClF2N3O3
- Structure:
- Chemical Name:
- Sitagliptin Carbamoyl -D-Glucuronide
- CAS:
- 940002-59-5
- MF:
- C23H23F6N5O9
- Structure:
- Chemical Name:
- 5-Hydroxy Desloratadine
- CAS:
- 117811-12-8
- MF:
- C19H19ClN2O
- Structure:
- Chemical Name:
- D-Streptamine, o-3-amino-3-deoxy-alpha-D-glucopyranosyl-(1-6)-o-(6-amino-6-deoxy-alpha-D-glucopyranosyl-(1-4))-N(sup 3)-(4-amino-2-hydroxybutyryl)-2-deoxy-
- CAS:
- 50725-24-1
- MF:
- C22H43N5O13
- Structure:
- Chemical Name:
- N-Trityl Candesartan Ethyl Ester
- CAS:
- 856414-35-2
- MF:
- C45H38N6O3
- Structure:
- Chemical Name:
- 3-[4-(4-Chlorobenzoyl)phenoxy]-2-butanone (Fenofibrate IMpurity)
- CAS:
- 217636-47-0
- MF:
- C17H15ClO3
- Structure:
- Chemical Name:
- 5-(2-Chlorobenzyl)-thieno[3,2-c]pyridiniuM Chloride
- CAS:
- 53885-64-6
- MF:
- C14H11Cl2NS
- Structure:
- Chemical Name:
- ClarithroMycin 9-OxiMe
- CAS:
- 103450-87-9
- MF:
- C38H70N2O13
- Structure:
- Chemical Name:
- Desloratadine N-Hydroxypiperidine
- CAS:
- 1193725-73-3
- MF:
- C19H19ClN2O
- Structure:
- Chemical Name:
- O-DesMethyl Venlafaxine Cyclic IMpurity
- CAS:
- 1346601-55-5
- MF:
- C16H23NO2
- Structure:
- Chemical Name:
- rac-cis-2,3-Dichloro Sertraline Hydrochloride
- CAS:
- 1198084-29-5
- MF:
- C17H18Cl3N
- Structure:
- Chemical Name:
- 11β-Hydroperoxy Dienogest
- CAS:
- 106111-43-7
- MF:
- C20H25NO4
- Structure:
- Chemical Name:
- (E)-Olopatadine
- CAS:
- 113806-06-7
- MF:
- C21H23NO3
- Structure:
- Chemical Name:
- NeMadipine B
- CAS:
- 79925-38-5
- MF:
- C19H21Cl2NO4
- Structure:
- Chemical Name:
- N-[(3,4-DiMethoxy-2-pyridinyl)Methyl] Pantoprazole
- CAS:
- 957470-59-6
- MF:
- C24H24F2N4O6S
- Chemical Name:
- Lasmiditan Impurity 9
- Chemical Name:
- Letermovir Impurity 2
- Structure:
- Chemical Name:
- 1H-Imidazole-2-carboxylic acid
- CAS:
- 16042-25-4
- MF:
- C4H4N2O2
- Chemical Name:
- Olodaterol Impurity 19
- Structure:
- Chemical Name:
- 6α-Methyl Hydrocortisone 21-Acetate
- CAS:
- 1625-11-2
- MF:
- C24H34O6
- Structure:
- Chemical Name:
- 4-Epi-6-epi Doxycycline
- CAS:
- 97583-08-9
- MF:
- C22H24N2O8
- Structure:
- Chemical Name:
- Sertraline-d3 hydrochloride
- MF:
- C17H15Cl3D3N
- Structure:
- Chemical Name:
- Ethyl 3,4-O-Isopropylidene-5-O-methanesulfonylshikimate
- CAS:
- 204254-84-2
- MF:
- C13H20O7S
- Structure:
- Chemical Name:
- 2-PyrazinecarboxaMide, N,N',N''-[2,4,6-boroxintriyltris[[(1R)-3-Methylbutylidene]iMino[(1S)-2-oxo-1-(phenylMethyl)-2,1-ethanediyl]]]tris-
- CAS:
- 390800-88-1
- MF:
- C57H69B3N12O9
- Structure:
- Chemical Name:
- D-hydroxyphenylglycylamoxicillin)
- CAS:
- 188112-75-6
- MF:
- C24H26N4O7S
- Structure:
- Chemical Name:
- Salmeterol Related Compound B (10 mg) (4-{1-Hydroxy-2-[6-(4-phenylbutan-2-yloxy)hexylamino]ethyl}-2-(hydroxymethyl)phenol)
- CAS:
- 108928-81-0
- MF:
- C25H37NO4
- Structure:
- Chemical Name:
- N-[3-[3-(1-Piperidinylmethyl)phenoxy]propyl]amine
- CAS:
- 73278-98-5
- MF:
- C15H24N2O
- Structure:
- Chemical Name:
- 7,10-Bis-O-(2,2,2-trichloroethoxycarbonyl)-10-deacetylbaccatin III
- CAS:
- 95603-44-4
- MF:
- C35H38Cl6O14
- Structure:
- Chemical Name:
- 4-(3-AMino-phenyl)-Morpholin-3-one
- CAS:
- 1082495-22-4
- MF:
- C10H12N2O2
- Chemical Name:
- piperacillinylaMpicillin
- Chemical Name:
- Celecoxib iMpurity-B
- Chemical Name:
- EMtricitabine iMpurity B
- Structure:
- Chemical Name:
- (S,S)-1,7-diazatricyclo[7.3.0.07,11]dodecane-2,6,8,12-tetrone
- CAS:
- 14842-41-2
- MF:
- C10H10N2O4
- Structure:
- Chemical Name:
- 1-Hydroxy-7-Methoxy-1,2,3,4-tetrahydronaphthalene
- CAS:
- 32820-10-3
- MF:
- C11H14O2
- Structure:
- Chemical Name:
- BroMhexine Hydrochloride iMpurity DN-(2-AMino-5-broMobenzyl)-N-MethylcyclohexanaMine Dihydrochloride
- CAS:
- 132004-28-5
- MF:
- C14H21BrN2
- Structure:
- Chemical Name:
- 2-(DiMethylcarbaMoyl)benzoic acid, 97%
- CAS:
- 20320-37-0
- MF:
- C10H11NO3
- Structure:
- Chemical Name:
- RAC DESMETHYL CITALOPRAM HYDROCHLORIDE
- CAS:
- 97743-99-2
- MF:
- C19H19FN2O
- Structure:
- Chemical Name:
- rac-3-Oxo Atorvastatin SodiuM Salt
- CAS:
- 1391052-00-8
- MF:
- C33H34FN2NaO5
- Structure:
- Chemical Name:
- 2-Demethoxy-4-methoxy urapidil
- CAS:
- 34661-79-5
- MF:
- C20H29N5O3
- Structure:
- Chemical Name:
- Ribavirin IMpurity F
- CAS:
- 58151-87-4
- MF:
- C10H14N4O6
- Structure:
- Chemical Name:
- 4-[-((-((4-(5-(Bis(2-hydroxyethyl)aMino)-1-Methyl-1H-benzo[d]iMidazol-2-yl)butanoyl)oxy)ethyl)(2-hydroxyethyl)aMino)-1-Methyl-1H-benzo[d]iMidazol-2-yl)butanic Acid
- CAS:
- 1228551-91-4
- MF:
- C32H41Cl3N6O4
- Structure:
- Chemical Name:
- 3-(6,7-Dihydro-2-Methyl-7-oxo-3-propyl-2H-pyrazolo[4,3-d]pyriMidin-5-yl)-4-ethoxy-benzenesulfonyl Chloride
- CAS:
- 501120-42-9
- MF:
- C17H19ClN4O4S
- Structure:
- Chemical Name:
- (3R,4S)-rel-3-[(1,3-Benzodioxol-5-yloxy)Methyl]-4-(4'-fluoro[1,1'-biphenyl]-4-yl)-piperidine Hydrochloride
- CAS:
- 1217655-87-2
- MF:
- C25H25ClFNO3
- Structure:
- Chemical Name:
- (16α)-16,17-[Butylidenebis(oxy)]-21-hydroxypregna-1,4-diene-3,11,20-trione
- CAS:
- 216453-74-6
- MF:
- C25H32O6
- Structure:
- Chemical Name:
- 6(S)-Hydroperoxy Simvastatin
- CAS:
- 149949-01-9
- MF:
- C25H38O7
- Structure:
- Chemical Name:
- Russupteridine IV
- CAS:
- 2535-20-8
- MF:
- C13H18N4O6
- Structure:
- Chemical Name:
- 2-[(1-Benzylpiperidin-4-yl)hydroxyMethyl]-5,6-diMethoxyindan-1-one
- CAS:
- 197010-20-1
- MF:
- C24H29NO4
- Structure:
- Chemical Name:
- 5,6-trans-Ergocalciferol
- CAS:
- 51744-66-2
- MF:
- C28H44O
- Structure:
- Chemical Name:
- 2-isonicotinoyl-5,6-diMethoxy-2,3-dihydro-1H-inden-1-one
- CAS:
- 923571-15-7
- MF:
- C17H15NO4
- Structure:
- Chemical Name:
- 4-(2-nitrophenyl)Morpholin-3-one
- CAS:
- 845729-41-1
- MF:
- C10H10N2O4
- Structure:
- Chemical Name:
- 2-Naphthalenecarboxylic acid, 4-hydroxy-8-Methyl-
- CAS:
- 16036-18-3
- MF:
- C12H10O3
- Chemical Name:
- Ruxolitinib Impurity 1
- Chemical Name:
- Flomoxef Impurity IV
- Chemical Name:
- NA
- Chemical Name:
- Cetrorelix Impurity 15
- Chemical Name:
- Brivaracetam Impurity 46
- Chemical Name:
- NA
- Chemical Name:
- Peramivir Intermediate Impurity 38
- Chemical Name:
- Ticagrelor impurity P drops
- Chemical Name:
- NA
- Chemical Name:
- Paclitaxel EP impurity drops
- Chemical Name:
- Oxacillin sodium EP impurity J
- Chemical Name:
- Piperacillin Sodium EP Impurity P
- Chemical Name:
- (S)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-(dimethylamino)butanamide
- Chemical Name:
- Ertapenem Impurity B(USP)
- Structure:
- Chemical Name:
- INDEX NAME NOT YET ASSIGNED
- CAS:
- 2458312-06-4
- MF:
- C27H30N2O6
- Structure:
- Chemical Name:
- 15(R)-17-PHENYL TRINOR PROSTAGLANDIN F2ALPHA
- CAS:
- 41639-71-8
- MF:
- C23H32O5
- Chemical Name:
- (5R,6S)-6-((R)-1-hydroxyethyl)-3-((R)-tetrahydrofuran-2-yl)-4-thia-1-azabicyclo[3.2.0]hept-2-en-7-one
- Structure:
- Chemical Name:
- Acetamide, N-(4-hydroxyphenyl)-N-nitroso-
- CAS:
- 146897-60-1
- MF:
- C8H8N2O3
- Chemical Name:
- RICE BRAN OIL
- CAS:
- 68553-81-1
- Structure:
- Chemical Name:
- 3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-[4-(1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl]-
- CAS:
- 2402776-83-2
- MF:
- C16H17N7O2S
- Chemical Name:
- Iohexol ImpuritiesE
- Structure:
- Chemical Name:
- TERT-BUTYL (R)-6-CHLORO-5-HYDROXY-3-OXOHEXANOATE
- CAS:
- 404958-08-3
- MF:
- C10H17ClO4
- Chemical Name:
- 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-yl)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine
- Chemical Name:
- Bumetanide Photodegradable Impurity 16
- Chemical Name:
- Bisoprolol Impurity 47
- Chemical Name:
- Gadobutrol Impurity 11(Ammonium salt)
- Chemical Name:
- Flomoxef Impurity F
- Chemical Name:
- Tegoprazan Impurity 15
- Chemical Name:
- Nirmatrelvir Impurity 8
- Chemical Name:
- Nirmatrelvir Impurity 2
- Chemical Name:
- Roxadustat Impurity 17
- Chemical Name:
- Perospirone Impurity 20
- CAS:
- 1002359-81-0
- Chemical Name:
- Dolutegravir Impurity 19
- Chemical Name:
- Cephalexin Impurity I
- Chemical Name:
- Fondaparinux sodium impurity 6
- Chemical Name:
- Fondaparinux sodium impurity 2
- Chemical Name:
- Oxacillin sodium Impurity I
- Chemical Name:
- Mixture of Cefoxitin Impurity E&F
- Chemical Name:
- Revefenacin Impurity 22
- Chemical Name:
- Lasmiditan Impurity 7
- Chemical Name:
- Febuxostat impurity BAC
- Structure:
- Chemical Name:
- 4-(3,4-DICHLOROPHENYL)-1,2,3,4-TETRAHYDRO-1-NAPHTHALENOL
- CAS:
- 866018-46-4
- MF:
- C16H14Cl2O
- Chemical Name:
- Ethacridine Impurity 12