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:
- 1,3,5-Tri-O-benzoyl-2-deoxy-2-fluoro-α-D-ribofuranose
- CAS:
- 704916-12-1
- MF:
- C26H21FO7
- Structure:
- Chemical Name:
- Chlorpheniramine
- CAS:
- 78539-96-5
- MF:
- C16H19ClN2
- Structure:
- Chemical Name:
- 9-(2,5-d|Dioxo-L-3-aMino-1-pyrrolidineacetic acid)-10-deglycine DaptoMycin
- CAS:
- 121869-35-0
- MF:
- C72H99N17O25
- Structure:
- Chemical Name:
- (1S,2S,5S)-4-[2-[2-(6,6-DiMethylbicyclo[3.1.1]hept-2-yl)ethoxy]ethyl]Morpholine
- CAS:
- 38284-47-8
- MF:
- C17H31NO2
- Structure:
- Chemical Name:
- [4-(4-AMino-6-hydroxy-7-Methoxy-2-quinazolinyl)-1-piperazinyl](tetrahydro-2-furanyl)Methanone
- CAS:
- 105356-89-6
- MF:
- C18H23N5O4
- Structure:
- Chemical Name:
- 2,2'-[4-(2-Methylpropoxy)-1,3-phenylene]bis[4-Methyl-5-thiazolecarboxylic Acid 5,5'-DiMethyl Ester
- CAS:
- 1330632-47-7
- MF:
- C22H24N2O5S2
- Structure:
- Chemical Name:
- 2-(DiethylaMino)-N-(2,4-diMethylphenyl)acetaMide Hydrochloride
- CAS:
- 17289-54-2
- MF:
- C14H23ClN2O
- Structure:
- Chemical Name:
- 3-(5-Methyl-1H-iMidazol-1-yl)-5-(trifluoroMethyl)benzenaMine
- CAS:
- 641571-16-6
- MF:
- C11H10F3N3
- Structure:
- Chemical Name:
- 4-[[3-(4-Methylphenyl)-3-oxo-1-(trifluoroMethyl)propylidene]aMino]benzenesulfonaMide
- CAS:
- 1061214-09-2
- MF:
- C17H15F3N2O3S
- Structure:
- Chemical Name:
- 5-(Ethoxycarbonyl)-2-(hydroxyMethyl-6-Methyl-4-(3-nitrophenyl)nicotinic Acid
- CAS:
- 89267-43-6
- MF:
- C17H16N2O7
- Chemical Name:
- 9-L-β-Aspartic acid-daptoMycin
- CAS:
- 123180-72-3
- MF:
- C72H101N17O26
- Structure:
- Chemical Name:
- Chlorhexidine Digluconate IMpurity K
- CAS:
- 1381962-77-1
- MF:
- C22H29Cl2N9O
- Structure:
- Chemical Name:
- Cyclopropyl 3-Fluorobenzyl Ketone
- CAS:
- 952722-64-4
- MF:
- C11H11FO
- Structure:
- Chemical Name:
- Linear DaptoMycin
- CAS:
- 883991-21-7
- MF:
- C72H103N17O27
- Structure:
- Chemical Name:
- N,N-DiMethylaMidino) Urea
- CAS:
- 98026-16-5
- MF:
- C4H10N4O
- Structure:
- Chemical Name:
- rac Dehydro-O-desMethyl Venlafaxine
- CAS:
- 1346600-38-1
- MF:
- C16H23NO
- Structure:
- Chemical Name:
- 3-HYDROXY DESLORATADINE HCL
- CAS:
- 119410-08-1
- MF:
- C19H19ClN2O
- Structure:
- Chemical Name:
- 2-Fluoro-α-(2-methyl-1-oxopropyl)-γ-oxo-N,β-diphenyl-benzenebutanamide
- CAS:
- 1797905-42-0
- MF:
- C26H24FNO3
- Structure:
- Chemical Name:
- ACETAMINOPURINE
- CAS:
- 6034-68-0
- MF:
- C7H7N5O
- Structure:
- Chemical Name:
- Quetiapine Hydroxy Impurity
- CAS:
- 329216-67-3
- MF:
- C19H21N3OS
- Structure:
- Chemical Name:
- 7-[4-(2-Piperidinyl)ethoxy]benzoyl Raloxifene (Raloxifene Impurity)
- CAS:
- 1159977-58-8
- MF:
- C42H44N2O6S
- Structure:
- Chemical Name:
- rac N-Demethyl Promethazine Hydrochloride
- CAS:
- 60113-77-1
- MF:
- C16H19ClN2S
- Structure:
- Chemical Name:
- Lincomycin B Hydrochloride
- CAS:
- 11021-35-5
- MF:
- C17H33ClN2O6S
- Chemical Name:
- Flucloxacillin impurity C
- Structure:
- Chemical Name:
- 1-[2-amino-1-(4-hydroxyphenyl)ethyl]cyclohexanol
- CAS:
- 149289-29-2
- MF:
- C14H21NO2
- Structure:
- Chemical Name:
- (2E)-3-(Dimethylamino)-1-(3-pyridyl)prop-2-en-1-one
- CAS:
- 123367-26-0
- MF:
- C10H12N2O
- Structure:
- Chemical Name:
- 5-(2R)-2-Oxiranyl-8-benzyloxy-2(1H)-quinolinone
- CAS:
- 173140-90-4
- MF:
- C18H15NO3
- Structure:
- Chemical Name:
- Methyl-5-chlorothiophene-2-carboxylate
- CAS:
- 35475-03-7
- MF:
- C6H5ClO2S
- Structure:
- Chemical Name:
- 3-Dechloro Sertraline Hydrochloride
- CAS:
- 79646-00-7
- MF:
- C17H19Cl2N
- Structure:
- Chemical Name:
- 7-DeMethyl Ivabradine
- CAS:
- 304462-60-0
- MF:
- C26H34N2O5
- Structure:
- Chemical Name:
- 8-Dechloro-9-chloro Loratadine
- CAS:
- 109537-11-3
- MF:
- C22H23ClN2O2
- Structure:
- Chemical Name:
- Acyclovir N-Ethyl-L-valinate Hydrochloride
- CAS:
- 1346617-49-9
- MF:
- C15H25ClN6O4
- Structure:
- Chemical Name:
- AMikacin B
- CAS:
- 48237-20-3
- MF:
- C22H44N6O12
- Structure:
- Chemical Name:
- Carboxy Gliclazide
- CAS:
- 38173-52-3
- MF:
- C15H19N3O5S
- Structure:
- Chemical Name:
- Dehydro RifaxiMin
- CAS:
- 80621-76-7
- MF:
- C43H49N3O11
- Structure:
- Chemical Name:
- N,N'-Desethylene Levofloxacin Hydrochloride
- CAS:
- 151250-76-9
- MF:
- C16H18FN3O4
- Structure:
- Chemical Name:
- rac 3-Deacetyl-3-butanoyl Acebutolol Hydrochloride
- CAS:
- 57898-71-2
- MF:
- C20H33ClN2O4
- Structure:
- Chemical Name:
- rac Deoxy-O-desMethyl Venlafaxine
- CAS:
- 1346605-18-2
- MF:
- C16H25NO
- Structure:
- Chemical Name:
- 2-Keto ZolpideM
- CAS:
- 400038-68-8
- MF:
- C19H19N3O2
- Structure:
- Chemical Name:
- N-ForMyl Oxcarbazepine
- CAS:
- 1346601-76-0
- MF:
- C16H12N2O3
- Structure:
- Chemical Name:
- OseltaMivir Acid Methyl Ester
- CAS:
- 208720-71-2
- MF:
- C15H26N2O4
- Structure:
- Chemical Name:
- 2'-[(1E)-2-[4-[[(2-carboxyethyl)aMino]carbonyl]phenyl]diazenyl] Balsalazide
- CAS:
- 1346606-53-8
- MF:
- C27H24N6O9
- Structure:
- Chemical Name:
- 7β-Fulvestrant
- CAS:
- 407577-53-1
- MF:
- C32H47F5O3S
- Structure:
- Chemical Name:
- 1,3-Di-HABA KanaMycin A
- CAS:
- 927821-99-6
- MF:
- C26H50N6O15
- Structure:
- Chemical Name:
- Dapagliflozin Tetraacetate
- CAS:
- 461432-25-7
- MF:
- C29H33ClO10
- Structure:
- Chemical Name:
- Atorvastatin Lactam Lactone
- CAS:
- 1795791-15-9
- MF:
- C33H31FN2O5
- Structure:
- Chemical Name:
- Vinorelbine N'b-Oxide Sulfate Salt
- CAS:
- 74075-34-6
- MF:
- C45H54N4O9
- Structure:
- Chemical Name:
- Linagliptin iMpurity G
- CAS:
- 668270-11-9
- MF:
- C25H28N8O2
- Chemical Name:
- Tadalafil EP IMpurity F
- Structure:
- Chemical Name:
- (2R,3R,4R,5S)-5-(4-benzaMido-2-oxopyriMidin-1(2H)-yl)-2-((benzoyloxy)Methyl)-4-fluoro-4-Methyltetrahydrofuran-3-yl benzoate
- CAS:
- 874638-94-5
- MF:
- C31H26FN3O7
- Structure:
- Chemical Name:
- CefuroxiMe sodiuM iMpurity B
- MF:
- C16H16N4NaO8S
- Structure:
- Chemical Name:
- Fasudil N-hydroxy iMpurity
- CAS:
- 1350827-92-7
- MF:
- C14H17N3O3S
- Structure:
- Chemical Name:
- TaMsulosin IMpurity A
- MF:
- C20H28N2O5S
- Structure:
- Chemical Name:
- 1-((2'-cyanobiphenyl-4-yl)Methyl)-2-ethoxy-1H-benziMidazole-7-carboxylic acid
- CAS:
- 632322-61-3
- MF:
- C24H19N3O3
- Structure:
- Chemical Name:
- 5-Methoxy-2-Hydroxy Benzimidazole
- CAS:
- 208-75-3
- MF:
- C13H9N
- Structure:
- Chemical Name:
- SODIUM CAMPTOTHECIN
- CAS:
- 25387-67-1
- MF:
- C20H17N2NaO5
- Structure:
- Chemical Name:
- (5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-yl)-L-cysteine
- CAS:
- 2238849-52-8
- MF:
- C13H15N3O3S
- Chemical Name:
- isopropyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxopiperidin-1-yl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate
- Structure:
- Chemical Name:
- Dantrolene Related Compound B (50 mg) (5-(4-nitrophenyl)-2-furaldehyde-(2-carboxymethyl) semicarbazone)
- CAS:
- 57268-33-4
- MF:
- C14H12N4O6
- Structure:
- Chemical Name:
- Doxazosin Related Compound F (15 mg) (N,N'-bis(1,4-benzodioxane-2-carbonyl)piperazine)
- CAS:
- 617677-53-9
- MF:
- C22H22N2O6
- Structure:
- Chemical Name:
- Verapamil Related Compound A (50 mg) (3,4-Dimethoxy-alpha-[3-(methylamino)propyl]-alpha-(1-methylethyl)-benzeneacetonitrile monohydrochloride)
- CAS:
- 67775-97-7
- MF:
- C17H27ClN2O2
- Structure:
- Chemical Name:
- Ethanediamide, N1-(5-chloro-2-pyridinyl)-N2-[(1R,2S,4R)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]-
- CAS:
- 1255529-23-7
- MF:
- C24H30ClN7O4S
- Structure:
- Chemical Name:
- (1S,2S,3R,5S)-3-(7-((1S,2R)-2-(3,4-difluorophenyl)cyclopropylaMino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
- CAS:
- 2096989-56-7
- MF:
- C23H28F2N6O4S
- Chemical Name:
- Fosaprepitant iMpurity
- Chemical Name:
- Apixaban iMpurity 1
- Chemical Name:
- Azilsartan iMpurity H
- Chemical Name:
- Azilsartan iMpurity M
- Chemical Name:
- bortezoMib iMpurity F
- Chemical Name:
- cefoxitin iMpurity A
- Structure:
- Chemical Name:
- 3-Morpholinone, 4-(2-aMinophenyl)-
- CAS:
- 1082588-73-5
- MF:
- C10H12N2O2
- Structure:
- Chemical Name:
- (R)-N-(1-(naphthalen-1-yl)ethyl)-3-(4-(trifluoroMethyl)phenyl)propan-1-aMine
- CAS:
- 1428185-71-0
- MF:
- C22H22F3N
- Structure:
- Chemical Name:
- 1-Piperidinepropanenitrile, 4-Methyl-3-(Methyl-7H-pyrrolo[2,3-d]pyriMidin-4-ylaMino)-β-oxo-
- CAS:
- 344418-92-4
- MF:
- C16H20N6O
- Structure:
- Chemical Name:
- Erlotinib impurity A
- CAS:
- 183321-85-9
- MF:
- C21H20ClN3O3
- Structure:
- Chemical Name:
- 1,3-Dioxane-4,6-dione, 5-[[(3,4-diMethoxyphenyl)aMino]Methylene]-2,2-diMethyl-
- CAS:
- 213699-53-7
- MF:
- C15H17NO6
- Structure:
- Chemical Name:
- (2R,3R)-2-[(1S)-1-[3,5-Bis(trifluoroMethyl)phenyl]ethoxy]-3-(4-fluorophenyl)Morpholine hydrochloride
- CAS:
- 1333998-21-2
- MF:
- C20H19ClF7NO2
- Structure:
- Chemical Name:
- Budesonide iMpurity
- CAS:
- 192057-49-1
- MF:
- C24H32O6
- Chemical Name:
- dextroMethorphan iMpurity
- Structure:
- Chemical Name:
- Fluticasone IMpurity
- CAS:
- 397864-58-3
- MF:
- C27H30F2O6S
- Chemical Name:
- Valdecoxib iMpurity
- Chemical Name:
- Fluconazole IMpurity-H
- Structure:
- Chemical Name:
- Retigabine Dihydrochloride Impurity
- CAS:
- 1432063-93-8
- MF:
- C16H19ClFN3O2
- Structure:
- Chemical Name:
- Adrenaline IMpurity F
- CAS:
- 78995-75-2
- MF:
- C9H13NO5S
- Structure:
- Chemical Name:
- Anastrozole IMpurity (alfa1 , alfa1, alfa3, alfa3-TetraMethyl-5-(1H-1,2,4-triazol-1-ylMethyl)-1,3-Benzenediacetic acid)
- CAS:
- 1338800-81-9
- MF:
- C17H21N3O4
- Structure:
- Chemical Name:
- Apixaban IMpurity 4 (BMS-728626-01)
- CAS:
- 1801881-22-0
- MF:
- C27H28N4O5
- Chemical Name:
- AtracuriuM IMpurity C1 (trans-Monoacrylate)
- Chemical Name:
- AzithroMycin IMpurity C
- Chemical Name:
- AztreonaM IMpurity D
- Structure:
- Chemical Name:
- Busulfan IMpurity 1
- CAS:
- 1797106-48-9
- MF:
- C6H14O5S2
- Structure:
- Chemical Name:
- Deferasirox Ethyl Ester
- CAS:
- 201530-79-2
- MF:
- C23H19N3O4
- Structure:
- Chemical Name:
- MetoclopraMide IMpurity F
- CAS:
- 38339-95-6
- MF:
- C13H20ClN3O2
- Chemical Name:
- Metronidazole IMpurity E
- Chemical Name:
- Propofol IMpurity H
- Structure:
- Chemical Name:
- R-(-)-O-DesMethyl-Venlafaxine-d6
- CAS:
- 1062609-96-4
- MF:
- C16H25NO2
- Chemical Name:
- Ribavirin IMp. C (EP)
- Structure:
- Chemical Name:
- SalMeterol IMpurity B
- MF:
- C25H37NO4
- Structure:
- Chemical Name:
- Sitagliptin N-Phoshate IMpurity
- CAS:
- 1351498-25-3
- MF:
- C16H16F6N5O4P
- Chemical Name:
- SulbactaM IMpurity E
- Structure:
- Chemical Name:
- TriMethopriM IMpurity A
- CAS:
- 213745-86-9
- MF:
- C15H20N4O3
- Chemical Name:
- Varenicline Metadinitro IMpurity