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:
- (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:
- (5R)-ethyl 5-((1R,3aS,7aR)-4-((E)-2-((3S,5R)-3,5-bis(tert-butyldiMethylsilyloxy)-2-Methylenecyclohexylidene)ethyl)-7a-Methyloctahydro-1H-inden-1-yl)hexanoate
- CAS:
- 169900-32-7
- MF:
- C39H70O4Si2
- 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
- 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:
- 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
- Structure:
- Chemical Name:
- Irbesartan IMpurity E
- MF:
- C25H28N6O
- Structure:
- Chemical Name:
- LeflunoMide EP IMpurity G
- CAS:
- 724429-16-7
- MF:
- C12H12N2O2
- Chemical Name:
- Telmisartan impurity C
- 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:
- 2,4'-Diamino[sulfonylbisbenzene]
- CAS:
- 27147-69-9
- MF:
- C12H12N2O2S
- Structure:
- Chemical Name:
- 2-P-TOLYLOXYMETHYL-OXIRANE
- CAS:
- 2186-24-5
- MF:
- C10H12O2
- Structure:
- Chemical Name:
- 3-Hydroxyazobenzene
- CAS:
- 2437-11-8
- Structure:
- Chemical Name:
- Astragalin 7-O-β-D-glucopyranoside
- CAS:
- 25615-14-9
- MF:
- C27H30O16
- Structure:
- Chemical Name:
- 4-(5-CHLORO-2-THIENYL)-1,3-THIAZOL-2-AMINE
- CAS:
- 123971-45-9
- MF:
- C7H5ClN2S2
- Structure:
- Chemical Name:
- α,α-Dibromo-o-tolunitrile
- CAS:
- 655-63-0
- MF:
- C8H5Br2N
- Structure:
- Chemical Name:
- 7-CHLORO-1-ETHYL-6-FLUORO-4-OXO-1,4-DIHYDRO-[1,8]NAPHTHYRIDINE-3-CARBOXYLIC ACID
- CAS:
- 79286-73-0
- MF:
- C11H8ClFN2O3
- Structure:
- Chemical Name:
- HYDRIDE-L
- CAS:
- 41639-74-1
- MF:
- C18H22O4
- 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
- Chemical Name:
- 3-bromo-5-((1-((4-methyl-5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl) methyl)-2-oxo-4-(trifluoromethyl)-1,2-dihydropyridin-3-yl)oxy) benzonitrile
- CAS:
- 2994626-87-6
- Structure:
- Chemical Name:
- O-Benzyl Posaconazole
- CAS:
- 170985-86-1
- MF:
- C44H48F2N8O4
- Structure:
- Chemical Name:
- 10-trans-Atorvastatin Acetonide tert-Butyl Ester
- CAS:
- 1105067-90-0
- MF:
- C40H47FN2O5
- Structure:
- Chemical Name:
- 3-Bromo Carbidopa
- CAS:
- 1246819-09-9
- MF:
- C10H13BrN2O4
- Structure:
- Chemical Name:
- (4S,6R)-6-(Cyanomethyl)-2,2-dimethyl-1,3-dioxane-4-acetic Acid tert-Butyl Ester
- CAS:
- 186508-95-2
- MF:
- C14H23NO4
- Structure:
- Chemical Name:
- (5R)-6-Cyano-5-hydroxy-3-oxo-hexanoic Acid tert-Butyl Ester
- CAS:
- 125988-01-4
- MF:
- C11H17NO4
- Structure:
- Chemical Name:
- (4-Carboxy-3-ethoxy)phenyl Acetic Acid (Repaglinide Impurity)
- CAS:
- 220438-80-2
- MF:
- C11H12O5
- Structure:
- Chemical Name:
- 2-Chloromethyl-3,5-dimethylpyridin-4-ol
- CAS:
- 220771-03-9
- MF:
- C8H10ClNO
- Structure:
- Chemical Name:
- (3S,5R)-6-Cyano-3,5-dihydroxy-hexanoic Acid tert-Butyl Ester
- CAS:
- 186508-94-1
- MF:
- C11H19NO4
- Structure:
- Chemical Name:
- 2-Methyl-6-[(4-methylphenyl)sulfonyl]-1,4,5,6-tetrahydroimidazo[4,5-d][1]benzazepine
- CAS:
- 717917-14-1
- MF:
- C19H19N3O2S
- Structure:
- Chemical Name:
- (1R-4S)-4-[[(1,1-dimethylethoxy)carbonyl]amino]- 2-Cyclopentene-1-carboxylic acid methyl ester
- CAS:
- 251326-99-5
- MF:
- C12H19NO4
- Structure:
- Chemical Name:
- O-Isobutyryl (R)-Fesoterodine
- CAS:
- 1208313-13-6
- MF:
- C30H43NO4
- Structure:
- Chemical Name:
- Isopropyl Itraconazole
- CAS:
- 89848-49-7
- MF:
- C34H36Cl2N8O4
- Structure:
- Chemical Name:
- (R)-(-)-Ibuprofen-d3
- CAS:
- 121702-86-1
- MF:
- C13H18O2
- Chemical Name:
- Itraconazole iMpurity E
- Structure:
- Chemical Name:
- Edoxaban Isomer (RRR)
- CAS:
- 1255529-24-8
- MF:
- C24H30ClN7O4S
- Structure:
- Chemical Name:
- 1-NaphthaleneacetaMide, 1,2,3,4-tetrahydro-7-Methoxy-
- CAS:
- 92041-01-5
- MF:
- C13H17NO2
- Structure:
- Chemical Name:
- DO2A
- CAS:
- 112193-75-6
- MF:
- C12H24N4O4
- 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
- Chemical Name:
- Ethacridine Impurity 12
- 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:
- 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
- Structure:
- Chemical Name:
- L-erythro-3-(3,4-Dihydroxyphenyl)serine
- CAS:
- 34047-62-6
- MF:
- C9H11NO5
- Chemical Name:
- Odaterol Impurity 35
- Chemical Name:
- Imimidistine impurity I
- Structure:
- Chemical Name:
- ethylmethylglycinexylidide
- CAS:
- 74634-66-5
- MF:
- C13H20N2O
- 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
- 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:
- 5-Hydroxy Desloratadine
- CAS:
- 117811-12-8
- MF:
- C19H19ClN2O
- Chemical Name:
- N-(2-((4-amino-6-(3-amino-5-fluorophenyl)pyrimidin-5-yl)oxy)ethyl)-N-methylacrylamide
- 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:
- (S,R,S,S)-Orlistat
- CAS:
- 111466-63-8
- MF:
- C29H53NO5