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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- Chemical Name:
- Pemetrexed Disodium Impurity 31-40
- Chemical Name:
- Paclitaxel EP impurity drops
- Chemical Name:
- Ticagrelor impurity PDD
- Chemical Name:
- Bimatoprost Impurity S
- Structure:
- Chemical Name:
- BIS(2,6-DIPHENYLPHENOXY)NIOBIUM(V) CHLOR
- CAS:
- 699012-35-6
- MF:
- C42H32Cl3NbO2
- Chemical Name:
- Brivaracetam Impurity 62
- Chemical Name:
- Lumateperone Impurity 4
- Chemical Name:
- SugammadexImpurity021
- Chemical Name:
- Pabocillin Impurity 28
- Chemical Name:
- Cefmetazole Sodium Impurity C
- Chemical Name:
- Ceftriaxone Sodium Oxide Impurity
- Chemical Name:
- 2-[4-(Azidomethyl)phenyl]benzamide
- Structure:
- Chemical Name:
- 1H-Benzimidazole-7-carboxylic acid, 1-[[2'-[4,5-dihydro-4-[(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl]-5-oxo-1,2,4-oxadiazol-3-yl][1,1'-biphenyl]-4-yl]methyl]-2-ethoxy-
- CAS:
- 1985638-55-8
- MF:
- C30H24N4O8
- Structure:
- Chemical Name:
- 2H-1,4-Benzoxazin-3(4H)-one, 8-[(1R)-2-bromo-1-hydroxyethyl]-6-(phenylmethoxy)-
- CAS:
- 2248125-51-9
- MF:
- C17H16BrNO4
- Structure:
- Chemical Name:
- Morpholine, 4-[4-(1,1-dimethylethoxy)-1,2,5-thiadiazol-3-yl]-
- CAS:
- 158636-99-8
- MF:
- C10H17N3O2S
- Chemical Name:
- Pemetrexed disodium Impurity 30
- Chemical Name:
- Ruxolitinib ImpurityABCDEFGHJKL
- Chemical Name:
- Avatrombopag Impurity 76
- Chemical Name:
- Rosuvastatin Impurity 153
- Chemical Name:
- Rosuvastatin Impurity 138
- Chemical Name:
- Rosuvastatin Impurity 127
- Structure:
- Chemical Name:
- 2-[4-[(2RS)-2-HYDROXY-3[(1-METHYLETHYL)AMINO]PROPOXY]PHENYL]ACETONITRILE
- CAS:
- 29277-73-4
- MF:
- C14H20N2O2
- Structure:
- Chemical Name:
- (-)-Nebivolol
- CAS:
- 118457-16-2
- MF:
- C22H25F2NO4
- Structure:
- Chemical Name:
- 2-Hydroxymethyl Olanzapine
- CAS:
- 174756-45-7
- MF:
- C17H20N4OS
- Structure:
- Chemical Name:
- 5-Hydroxymethyl Flucloxacillin
- CAS:
- 75524-31-1
- MF:
- C19H17ClFN3O6S
- Structure:
- Chemical Name:
- 6-Hydroxy-5-methoxy-1-indanone
- CAS:
- 90843-62-2
- MF:
- C10H10O3
- Structure:
- Chemical Name:
- 9-cis Acitretin
- CAS:
- 419534-31-9
- MF:
- C21H26O3
- Structure:
- Chemical Name:
- N-Desmethylvinblastine
- CAS:
- 18172-50-4
- MF:
- C45H56N4O9
- Structure:
- Chemical Name:
- Rabeprazole Sulfone
- CAS:
- 117976-47-3
- MF:
- C18H21N3O4S
- Structure:
- Chemical Name:
- 6-BROMO-3 H-ISOBENZOFURAN-1-ONE
- CAS:
- 19477-73-7
- MF:
- C8H5BrO2
- Structure:
- Chemical Name:
- L-erythro-3-(3,4-Dihydroxyphenyl)serine
- CAS:
- 34047-62-6
- MF:
- C9H11NO5
- Chemical Name:
- Imimidistine impurity I
- Structure:
- Chemical Name:
- ethylmethylglycinexylidide
- CAS:
- 74634-66-5
- MF:
- C13H20N2O
- Chemical Name:
- Avatrombopag Impurity 60 (Hydrochloride)
- Structure:
- Chemical Name:
- 1-(4-Isobutylphenyl)ethanol
- CAS:
- 40150-92-3
- MF:
- C12H18O
- Structure:
- Chemical Name:
- TRIMETHYL(3-HYDROXYPHENYL)AMMONIUMIODIDE
- CAS:
- 2498-27-3
- MF:
- C9H14INO
- Structure:
- Chemical Name:
- ACEMETACINTERT-BUTYLESTER
- CAS:
- 75302-98-6
- MF:
- C25H26ClNO6
- Structure:
- Chemical Name:
- 2-ETHYLHEXYLGLUCOPYRANOSIDE
- CAS:
- 125590-73-0
- MF:
- C14H28O6
- Structure:
- Chemical Name:
- Benzoic acid, 4-[(2S,4S)-4-ethoxy-2-piperidinyl]-
- CAS:
- 3040999-15-0
- MF:
- C14H19NO3
- Structure:
- Chemical Name:
- methyl (2R)-2-amino-3-(1H-indol-3-yl)propanoate
- CAS:
- 22032-65-1
- MF:
- C12H14N2O2
- Structure:
- Chemical Name:
- (5-BENZYLIDENE-4-OXO-2-THIOXO-THIAZOLIDIN-3-YL)-ACETIC ACID
- CAS:
- 82159-06-6
- MF:
- C12H9NO3S2
- Structure:
- Chemical Name:
- 3-NITROPHENYLACETYLENE
- CAS:
- 3034-94-4
- MF:
- C8H5NO2
- Structure:
- Chemical Name:
- Amlodipine Impurity 27
- CAS:
- 2832589-38-3
- MF:
- C26H29ClN2O7S
- Structure:
- Chemical Name:
- 3-(4-Methylimidazol-1-yl)-5-trifluoromethylbenzoic acid
- CAS:
- 641571-13-3
- MF:
- C12H9F3N2O2
- Structure:
- Chemical Name:
- 3-Morpholinopropyl bromide
- CAS:
- 125422-83-5
- MF:
- C7H14BrNO
- Structure:
- Chemical Name:
- 7-Phenyl-acetamido-deacetoxy-cephalosporanic-acid
- CAS:
- 27255-72-7
- MF:
- C16H16N2O4S
- Structure:
- Chemical Name:
- O-PROPIONYLBENZOIC ACID
- CAS:
- 2360-45-4
- MF:
- C10H10O3
- Structure:
- Chemical Name:
- 3-METHOXY-L-TYROSINE
- CAS:
- 300-48-1
- MF:
- C10H13NO4
- Structure:
- Chemical Name:
- (4S-cis)-6-(Cyanomethyl)-2,2-dimethyl-1,3-dioxane-4-acetic Acid 1,1-Dimethylethyl Ester
- CAS:
- 196085-85-5
- MF:
- C14H23NO4
- Structure:
- Chemical Name:
- (3S,4S,6S)-3-Hexyl-3,4,5,6-tetrahydro-4-hydroxy-6-undecyl-2H-pyran-2-one
- CAS:
- 68711-33-1
- MF:
- C22H42O3
- Structure:
- Chemical Name:
- (3S,4S,6S)-3-Hexyl-3,4,5,6-tetrahydro-4-hydroxy-6-undecyl-2H-pyran-2-one
- CAS:
- 68711-33-1
- MF:
- C22H42O3
- Structure:
- Chemical Name:
- Triacetyl Aloe-emodin (Impurity A)
- CAS:
- 25395-11-3
- MF:
- C21H16O8
- Structure:
- Chemical Name:
- ISOPROPYLAMINE HYDROCHLORIDE
- CAS:
- 15572-56-2
- MF:
- C3H10ClN
- Structure:
- Chemical Name:
- 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 3-[[(aminocarbonyl)oxy]methyl]-7-methoxy-7-[[(2S)-2-methoxy-2-(2-thienyl)acetyl]amino]-8-oxo-, (6R,7S)-
- CAS:
- 2395025-37-1
- MF:
- C17H19N3O8S2
- Structure:
- Chemical Name:
- Atorvastatin Impurity 83
- CAS:
- 1807481-00-0
- MF:
- C33H35F2N2NaO5
- Structure:
- Chemical Name:
- Loteprednol Etabonate Ethyl Ester (Prednisolone 20-Ethyl Ester)
- CAS:
- 182069-19-8
- MF:
- C25H34O7
- Structure:
- Chemical Name:
- Hexanamide, N-[(1S)-1-(aminocarbonyl)propyl]-3-(hydroxymethyl)-, (3R)-
- CAS:
- 2252417-17-5
- MF:
- C11H22N2O3
- Structure:
- Chemical Name:
- 1H-Benzimidazole-6-carboxylic acid, 4-hydroxy-2-methyl-1-(phenylmethyl)-, ethyl ester
- CAS:
- 1640981-16-3
- MF:
- C18H18N2O3
- Structure:
- Chemical Name:
- Benzoic acid, 2-chloro-4-nitro-, 2-(diethylamino)ethyl ester
- CAS:
- 10367-96-1
- MF:
- C13H17ClN2O4
- Chemical Name:
- (2R,3S)-3-amino-2-((Z)-2-(2-aminothiazol-4-yl)-2-(((2-carboxypropan-2-yl)oxy)imino)acetamido)butanoic acid
- Structure:
- Chemical Name:
- Benzenepropanoic acid, 2,4-dichloro-α-[(dimethylamino)methylene]-3-methyl-β-oxo-, ethyl ester
- CAS:
- 2241304-69-6
- MF:
- C15H17Cl2NO3
- Structure:
- Chemical Name:
- Benzonitrile, 4-[3-[(acetyloxy)methyl]-4-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan-2-yl)phenoxy]-
- CAS:
- 2227126-13-6
- MF:
- C22H24BNO5
- Structure:
- Chemical Name:
- (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl] carbamoyl]methylene]amino]oxy]-2-methylpropionic acid methyl ester
- CAS:
- 1255912-98-1
- MF:
- C14H19N5O8S2
- Structure:
- Chemical Name:
- Benzeneacetic acid, α-1-cyclopenten-1-yl-α-hydroxy-, (αR)-
- CAS:
- 185030-09-5
- MF:
- C13H14O3
- Structure:
- Chemical Name:
- 1-Piperazinecarboxaldehyde, 4-cyclohexyl-
- CAS:
- 2325305-38-0
- MF:
- C11H20N2O
- Structure:
- Chemical Name:
- 1H-Pyrrole-1-acetic acid, α-ethyl-2,5-dihydro-2-oxo-4-propyl-, (αS)-
- CAS:
- 2170761-55-2
- MF:
- C11H17NO3
- Chemical Name:
- Revefenacin ImpurityABCDEFGHJKL
- Chemical Name:
- Peramivir Impurity 57
- Structure:
- Chemical Name:
- 2-Thiazolamine, 4-(5-bromo-4-chloro-2-thienyl)-
- CAS:
- 1534575-19-3
- MF:
- C7H4BrClN2S2
- Chemical Name:
- NA
- Chemical Name:
- BrivaracetamImpurity ABCDEFGHJKL
- Structure:
- Chemical Name:
- DEHYDRO FELODIPINE-13C4
- CAS:
- 96382-71-7
- MF:
- C18H17Cl2NO4
- Chemical Name:
- Avatrombopag Impurity 24
- Chemical Name:
- (S)-2-(4-(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)-N-methylbenzamido)benzamido)pentanedioic acid
- Structure:
- Chemical Name:
- Cisatracurium besylate impurity 20
- CAS:
- 96946-54-2
- MF:
- C59H77N2O15S+
- Structure:
- Chemical Name:
- N-Desmethylondansetron
- CAS:
- 99614-14-9
- MF:
- C17H17N3O
- Chemical Name:
- Bimatoprost Impurity 17
- Chemical Name:
- Bumetanide Impurity 10
- Chemical Name:
- Cefoxitin EP Impurity E (R-methoxy cefoxitin)
- Structure:
- Chemical Name:
- 4(1H)-Pyrimidinone, 5-amino-6-chloro-2-(propylthio)-
- CAS:
- 2512210-21-6
- MF:
- C7H10ClN3OS
- Structure:
- Chemical Name:
- Carbamic acid, N-[(1S)-1-methyl-2-oxo-2-[3-(phenylmethoxy)phenyl]ethyl]-, phenylmethyl ester
- CAS:
- 2151127-61-4
- MF:
- C24H23NO4
- Structure:
- Chemical Name:
- 1-(chloromethyl)-4-(dichloromethyl)benzene
- CAS:
- 7398-44-9
- MF:
- C8H7Cl3
- Structure:
- Chemical Name:
- 4,4'-(propane-1,3-diyl)bismorpholine
- CAS:
- 48152-09-6
- MF:
- C11H22N2O2
- Structure:
- Chemical Name:
- TOPOTECANACETATE
- CAS:
- 123948-88-9
- MF:
- C25H27N3O7
- Structure:
- Chemical Name:
- Vancomycin Impurity J
- CAS:
- 2416251-24-4
- MF:
- C66H75Cl2N9O24
- Structure:
- Chemical Name:
- dimethyl 2,6-dimethyl-4-(4-nitrophenyl)-1,4-dihydropyridine-3,5-dicarb oxylate
- CAS:
- 21829-09-4
- MF:
- C17H18N2O6
- Structure:
- Chemical Name:
- Metronidazole IMpurity (1-Methyl-4-Nitro-1H-IMidazole)
- CAS:
- 143508-97-8
- MF:
- C2H3NO
- Structure:
- Chemical Name:
- benidipine
- CAS:
- 119009-45-9
- MF:
- C28H31N3O6
- Structure:
- Chemical Name:
- (S)-Phenylephrine hydrochloride
- CAS:
- 939-38-8
- MF:
- C9H14ClNO2
- Chemical Name:
- Odaterol Impurity 35
- Structure:
- Chemical Name:
- riboflavin 3',5'-bisphosphate
- CAS:
- 86108-26-1
- MF:
- C17H22N4O12P2
- Structure:
- Chemical Name:
- Notoginsenoside FP1
- CAS:
- 1004988-73-1
- MF:
- C47H80O18
- Structure:
- Chemical Name:
- 6 beta-hydroxycortisol
- CAS:
- 53-35-0
- MF:
- C21H30O6
- Structure:
- Chemical Name:
- 16-hydroxyclarithromycin
- CAS:
- 124412-58-4
- MF:
- C38H69NO14
- Structure:
- Chemical Name:
- 4-METHYL-3-[[1-OXO-2-(PROPYLAMINO)PROPYL]AMINO]-2-THIOPHENECARBOXYLIC ACID
- CAS:
- 114176-52-2
- MF:
- C12H18N2O3S