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:
- 1,2-Ethanediamine, N,N,N',N'-tetrakis(2-aminoethyl)-
- CAS:
- 4097-90-9
- MF:
- C10H28N6
- Structure:
- Chemical Name:
- Amoxicillin Impurity P
- MF:
- C16H19N3O5S
- Chemical Name:
- Ampicillin Impurity S
- Chemical Name:
- Cefdinir Impurity F (CP)
- Structure:
- Chemical Name:
- Flucloxacillin Sodium Impurity A
- CAS:
- 68728-50-7
- MF:
- C19H20ClFN3NaO6S
- Structure:
- Chemical Name:
- Oxacillin Sodium Impurity G(EP)
- CAS:
- 724695-30-1
- MF:
- C19H18ClN3O5S
- Chemical Name:
- Spectinomycin Impurity D
- Structure:
- Chemical Name:
- (4R,4aS,5aR,12aS)-9-[2-(tert-butylamino)acetamido]-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide
- MF:
- C29H39N5O8
- Structure:
- Chemical Name:
- Amifostine Impurity 3
- CAS:
- 41510-53-6
- MF:
- C5H15N2O3PS
- Chemical Name:
- Cefradine impurity C
- Structure:
- Chemical Name:
- Cefuroxime sodium impurity H
- MF:
- C16H16N4NaO8S
- Structure:
- Chemical Name:
- Bilastine N-Oxide
- CAS:
- 2069238-47-5
- MF:
- C28H37N3O4
- Chemical Name:
- Cefoxitin impurity F
- Structure:
- Chemical Name:
- Tenofovir Disoproxil Fumarate impurity N
- CAS:
- 1962114-92-6
- MF:
- C29H44N10O14P2
- Structure:
- Chemical Name:
- Prednisolone Impurity 7
- CAS:
- 61549-70-0
- MF:
- C21H26O6
- Structure:
- Chemical Name:
- Tenofovir Related Compound 10
- CAS:
- 16958-60-4
- MF:
- C8H11N5O
- Structure:
- Chemical Name:
- N-(4-methyl-3-(N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamido)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide
- MF:
- C31H33N7O2
- Structure:
- Chemical Name:
- N1-benzyl-N1,4-dimethyl-N3-(4-(pyridin-3-yl)pyrimidin-2-yl)benzene-1,3-diamine
- MF:
- C24H23N5
- Structure:
- Chemical Name:
- (E)-4-(((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3- yl)methyl)(methyl)amino)-4-oxobut-2-enoic acid
- MF:
- C21H18FN3O5S
- Structure:
- Chemical Name:
- Apremilast
- CAS:
- 1384439-80-8
- MF:
- C17H16N2O6S
- Structure:
- Chemical Name:
- TROXACITABINE
- CAS:
- 145511-98-4
- MF:
- C8H11N3O4
- Structure:
- Chemical Name:
- XXZJUZXKBFUPQH-IKGGRYGDSA-N
- CAS:
- 1618657-31-0
- MF:
- C18H17FO4
- Structure:
- Chemical Name:
- 2-CHLORO-N-(2,5-DIMETHYLPHENYL)ACETAMIDE
- CAS:
- 5177-35-5
- MF:
- C10H12ClNO
- Structure:
- Chemical Name:
- (+/-)-tert-Butyl 6-Chloro-5-hydroxy-3-oxohexanoate
- CAS:
- 319924-73-7
- MF:
- C10H17ClO4
- Structure:
- Chemical Name:
- (R)-2-(2-aminothiazol-4-yl)-N-(2-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)acetamide
- CAS:
- 1684452-80-9
- MF:
- C21H24N4O2S
- Structure:
- Chemical Name:
- 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic Acid 3-[2-[(3,3-Diphenylpropyl)methylamino]-1,1-dimethylethyl] 5-ethyl Ester Hydrochloride
- CAS:
- 210579-71-8
- MF:
- C37H44ClN3O6
- Structure:
- Chemical Name:
- 2-chloro-5-(2-fluorophenyl)-1H-pyrrole-3-carbaldehyde
- CAS:
- 2169267-53-0
- MF:
- C11H7ClFNO
- Structure:
- Chemical Name:
- 4-(4-(4-(4-(((3S,5S)-5-((1H-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-1-((2R,3S)-2-hydroxypentan-3-yl)-1H-1,2,4-triazol-5(4H)-one
- CAS:
- 2243785-99-9
- MF:
- C37H42F2N8O4
- Structure:
- Chemical Name:
- 5-(2-fluorophenyl)-N-methyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carboxamide
- CAS:
- 2054536-04-6
- MF:
- C17H14FN3O3S
- Chemical Name:
- Ozagrel Impurity 10
- Structure:
- Chemical Name:
- tris((5-(2-fluorophenyl)-1H-pyrrol-3-yl)methyl)amine
- MF:
- C33H27F3N4
- Chemical Name:
- Esmolol impurity C
- Structure:
- Chemical Name:
- (R)-(+)-(3-CHLORO-2-HYDROXYPROPYL)TRIMETHYLAMMONIUM CHLORIDE
- CAS:
- 117604-42-9
- MF:
- C6H15Cl2NO
- Structure:
- Chemical Name:
- REICHSTEIN'S SUBSTANCE S 21-ACETATE
- CAS:
- 640-87-9
- MF:
- C23H32O5
- Structure:
- Chemical Name:
- N,N'-(OXYDI-4,1-PHENYLENE)BISACETAMIDE
- CAS:
- 3070-86-8
- MF:
- C16H16N2O3
- Structure:
- Chemical Name:
- 3-(2-hydroxyethyl) 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
- CAS:
- 85677-95-8
- MF:
- C18H20N2O7
- Structure:
- Chemical Name:
- 3-isobutylisobenzofuran-1(3H)-one
- CAS:
- 199736-94-2
- MF:
- C12H14O2
- Structure:
- Chemical Name:
- isopropyl(4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl)pyrimidin-5-yl)(methyl)carbamate
- CAS:
- 625115-54-0
- MF:
- C22H23FN8O2
- Structure:
- Chemical Name:
- Malvidin 3-O-glucoside
- CAS:
- 18470-06-9
- MF:
- C23H25O12+
- Structure:
- Chemical Name:
- 6-Hydroxyluteolin 7-glucoside
- CAS:
- 54300-65-1
- MF:
- C21H20O12
- Structure:
- Chemical Name:
- (S)-Olodaterol
- CAS:
- 868049-50-7
- MF:
- C21H26N2O5
- Structure:
- Chemical Name:
- 5,6-DIHYDRO-3-METHYLAMINO-2H-1,4-THIAZIN-2-ONE OXIME
- CAS:
- 148639-72-9
- MF:
- C5H9N3OS
- Structure:
- Chemical Name:
- Moxifloxacin Impurity 37
- CAS:
- 1803729-19-2
- MF:
- C7H3ClF2O2
- Structure:
- Chemical Name:
- Nimodipine Impurity 12
- CAS:
- 39562-18-0
- MF:
- C19H22N2O6
- Chemical Name:
- Rosuvastatin Impurity 53
- Structure:
- Chemical Name:
- Sulbactam Impurity 8
- CAS:
- 75527-88-7
- MF:
- C8H10BrNO5S
- Structure:
- Chemical Name:
- Tenofovir Impurity 64
- CAS:
- 1878175-76-8
- MF:
- C13H23N5O8P2
- Chemical Name:
- Ticagrelor Impurity 65
- Structure:
- Chemical Name:
- Ticagrelor Impurity 72
- CAS:
- 1402150-11-1
- MF:
- C24H28F2N6O5S
- Chemical Name:
- Topiroxostat Impurity 18
- Structure:
- Chemical Name:
- Isorhamnetin 3,7-O-diglucoside
- CAS:
- 6758-51-6
- MF:
- C28H32O17
- Chemical Name:
- Afatinib Impurity 26
- Structure:
- Chemical Name:
- Amifostine Impurity 5
- CAS:
- 712255-27-1
- MF:
- C5H9BrN2
- Chemical Name:
- Amikacin EP Impurity E
- Structure:
- Chemical Name:
- Aztreonam Impurity 5
- CAS:
- 2195336-17-3
- MF:
- C4H10N2O5S
- Chemical Name:
- Canagliflozin Impurity 35
- Structure:
- Chemical Name:
- Cefazolin Impurity 7 (Cefazolin Trimethylsilyl Ester)
- CAS:
- 1072000-00-0
- MF:
- C17H22N8O4S3Si
- Chemical Name:
- Dapagliflozin Impurity 25
- Chemical Name:
- Doripenem Impurity 1
- Chemical Name:
- Erlotinib Impurity 54
- Chemical Name:
- Erlotinib Impurity 59
- Chemical Name:
- Etoposide Impurity 5
- Chemical Name:
- Olaparib Impurity 26
- Structure:
- Chemical Name:
- Oseltamivir Impurity 14
- CAS:
- 2081110-44-1
- MF:
- C16H28N2O4
- Chemical Name:
- Rocuronium bromide Impurity 35
- Chemical Name:
- Adefovir Impurity 5
- Chemical Name:
- Apremilast Impurity QJ
- Chemical Name:
- Apremilast Impurity TTN
- Chemical Name:
- AZD9291 Osimertinib Impurity 1
- Chemical Name:
- Dextrorotation lansoprazole Impurity I
- Chemical Name:
- Ivabradine Impurity 31
- Chemical Name:
- lansoprazole Impurity 28
- Chemical Name:
- Lincomycin sulfoxide Impurity 1
- Structure:
- Chemical Name:
- Olanzapine impurity Q
- MF:
- C17H20N4S
- Chemical Name:
- Palbociclib Impurity 32
- Chemical Name:
- Ropivacaine Impurity 32
- Chemical Name:
- Ropivacaine Impurity 41
- Chemical Name:
- Sugammadex sodium dimer
- Chemical Name:
- Sugammadex sodium Org49095 Impurity
- Chemical Name:
- Topiroxostat Impurity Ⅲ-2
- Structure:
- Chemical Name:
- Parecoxib Impurity 12
- CAS:
- 2229657-81-0
- MF:
- C19H18N2O4S
- Structure:
- Chemical Name:
- Afatinib impurity 29
- CAS:
- 1957132-02-3
- MF:
- C22H23ClFN5O2
- Structure:
- Chemical Name:
- Avibactam Impurity 44
- CAS:
- 2064219-22-1
- MF:
- C23H46N4O6S
- Chemical Name:
- Bortezomib Impurity W
- Structure:
- Chemical Name:
- Butyphthalide impurity 43
- CAS:
- 952412-99-6
- MF:
- C11H14O3
- Structure:
- Chemical Name:
- Cabozantinib impurity 23
- CAS:
- 406-00-8
- MF:
- C6H6FNO
- Structure:
- Chemical Name:
- Celecoxib Impurity 17
- CAS:
- 2247197-65-3
- MF:
- C17H14F3N3O4S
- Chemical Name:
- Dapoxetine impurity 21
- Chemical Name:
- Febuxostat Impurity 74
- Chemical Name:
- Febuxostat Impurity 79
- Chemical Name:
- Febuxostat Impurity 94
- Chemical Name:
- Fosaprepitant Impurity ELS
- Structure:
- Chemical Name:
- Lenvatinib Impurity 14
- CAS:
- 417719-45-0
- MF:
- C19H17ClN4O4
- Chemical Name:
- Lenvatinib Impurity 23
- Chemical Name:
- Olsalazine Impurity F
- Chemical Name:
- Regorafenib Impurity 19
- Chemical Name:
- Regorafenib Impurity 26
- Chemical Name:
- Sitafloxacin Impurity ZZ-B-01
- Structure:
- Chemical Name:
- Tofacitinib Impurity 3
- CAS:
- 1206825-36-6
- MF:
- C13H19N5
- Chemical Name:
- Tofacitinib Impurity 89