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:
- ERYTHROMYCIN IMPURITY N
- Chemical Name:
- Fesoterodine Impurity 12
- Chemical Name:
- Dexamethasone EP impurities D
- Chemical Name:
- Palbociclib impurity LMAP
- Structure:
- Chemical Name:
- (3R,3'R)-3,3'-((((S)-1-amino-1-oxobutan-2-yl)azanediyl)bis(methylene))dihexanoic acid
- MF:
- C18H34N2O5
- Structure:
- Chemical Name:
- Acetaminophen EP Impurity L
- MF:
- C8H9NO2
- Chemical Name:
- Anagrelide Impurity 2 HCl
- Structure:
- Chemical Name:
- Mizolastine Impurity N
- CAS:
- 108612-60-8
- MF:
- C25H27FN6O
- Structure:
- Chemical Name:
- (R)-4-(2-(benzyl(methyl)amino)-1-hydroxyethyl)benzene-1,2-diol
- CAS:
- 317351-40-9
- MF:
- C16H19NO3
- Structure:
- Chemical Name:
- N,N'-Bis(4-hydroxyphenyl)hydrazine
- CAS:
- 158905-63-6
- MF:
- C12H12N2O2
- Chemical Name:
- Droxidopa Impurity M
- Chemical Name:
- Vigabatrin Impurity 2
- Chemical Name:
- Aripiprazole peroxide degradation Impurity (MW:464Da)
- Chemical Name:
- Zileuton Impurity (MW = 279.31 Da)
- Chemical Name:
- 3'-chloro-3'-deoxythymidine (zidovudine impurity)
- Chemical Name:
- Rivaroxaban Impurity 81
- Chemical Name:
- Salbutamol Impurity 37
- Chemical Name:
- Gadobutrol Impurity 21
- Structure:
- Chemical Name:
- 13-Cis Vitamin A Palmitate
- CAS:
- 26771-20-0
- MF:
- C36H60O2
- Structure:
- Chemical Name:
- Apixaban Amino Acid Impurity
- CAS:
- 2206825-87-6
- MF:
- C25H27N5O5
- Structure:
- Chemical Name:
- Bortezomib Impurity 52
- CAS:
- 87304-47-0
- MF:
- C15H26BClO2
- Structure:
- Chemical Name:
- Moxifloxacin Impurity 20 HCl
- CAS:
- 959347-97-8
- MF:
- C21H25N3O4
- Structure:
- Chemical Name:
- 2-amino-3,5-dibromo-N-((1r,4r)-4-hydroxycyclohexyl)benzamide
- CAS:
- 105735-86-2
- MF:
- C13H16Br2N2O2
- Structure:
- Chemical Name:
- Palonosetron Impurity TM1-RR
- CAS:
- 1022895-91-5
- MF:
- C15H23ClN2
- Chemical Name:
- Eltrombopag Impurity 6
- Structure:
- Chemical Name:
- (1r,4r)-4-((2-amino-3-bromobenzyl)amino)cyclohexanol hydrochloride
- MF:
- C13H20BrClN2O
- Structure:
- Chemical Name:
- (1s,4s)-4-((2-amino-5-bromobenzyl)amino)cyclohexanol hydrochloride
- CAS:
- 5579-35-1
- MF:
- C13H20BrClN2O
- Chemical Name:
- Moxifloxacin oxide Impurity
- Chemical Name:
- Edaravone Impurity 18
- Chemical Name:
- Linagliptin Impurity 47
- Structure:
- Chemical Name:
- (3R,5S,E)-7-(4-(4-fluorophenyl)-2-((2-hydroxy-N,2-dimethylpropyl)sulfonamido)-6-isopropylpyrimidin-5-yl)-3,5-dihydroxyhept-6-enoic acid
- CAS:
- 1715120-13-0
- MF:
- C25H34FN3O7S
- Chemical Name:
- Cabozantinib impurity 28
- Chemical Name:
- Cabozantinib impurity 33
- Chemical Name:
- Ondansetron Impurity 2
- Chemical Name:
- Rivaroxaban Degradation Impurity C
- Structure:
- Chemical Name:
- Irsogladine Impurity DQJ
- CAS:
- 61382-84-1
- MF:
- C9H6Cl2N4O
- Structure:
- Chemical Name:
- Pregabalin Impurity 7
- CAS:
- 70767-77-0
- MF:
- C8H13NO3
- Structure:
- Chemical Name:
- Pregabalin Impurity 13
- CAS:
- 1089315-68-3
- MF:
- C7H11NO3
- Chemical Name:
- Pralatrexate Impurity 7
- Chemical Name:
- Pitavastatin Impurity 39
- Chemical Name:
- Dapoxetine impurity 31
- Structure:
- Chemical Name:
- 2-Desisopropyl-2-phenyl Repaglinide
- CAS:
- 107362-12-9
- MF:
- C30H34N2O4
- Structure:
- Chemical Name:
- 2-(3-CHLOROPHENYL)-2-CYANO-1-(3-PYRIDINYL)-1-ETHANONE
- CAS:
- 114444-10-9
- MF:
- C14H9ClN2O
- Chemical Name:
- Flucloxacillin sodium EP Impurity E
- Chemical Name:
- Pyrazole
- Chemical Name:
- NA
- Structure:
- Chemical Name:
- Aristolactam IIIa N-β-glucoside
- CAS:
- 80311-26-8
- MF:
- C22H19NO9
- Structure:
- Chemical Name:
- METOPROLOL IMPURITY D
- MF:
- C15H25NO3
- Chemical Name:
- NITRENDIPINE IMPURITY A
- Structure:
- Chemical Name:
- TAMSULOSIN IMPURITY D
- MF:
- C20H28N2O5S
- Structure:
- Chemical Name:
- Macitentan Hydroxy amine Impurity
- CAS:
- 2211059-05-9
- MF:
- C12H12BrN3O2
- Structure:
- Chemical Name:
- 1,3-diethyl-1,3-dimethylurea
- CAS:
- 31468-19-6
- MF:
- C7H16N2O
- Structure:
- Chemical Name:
- 2,4(1H,3H)-Pyrimidinedione, 6-[(3R)-3-amino-1-piperidinyl]-3-methyl-
- CAS:
- 2276323-24-9
- MF:
- C10H16N4O2
- Structure:
- Chemical Name:
- 7H-Purine-7-acetic acid, 1,2,3,6-tetrahydro-1,3-dimethyl-2,6-dioxo-, ethyl ester
- CAS:
- 7029-96-1
- MF:
- C11H14N4O4
- Chemical Name:
- Lenvatinib Impurity 36
- Chemical Name:
- Sitafloxacin Impurity 19
- Chemical Name:
- Febuxostat Impurity 97
- Chemical Name:
- Dapoxetine impurity 32
- Chemical Name:
- Olprinone Impurity D
- Chemical Name:
- Atracurium Impurity 30
- Chemical Name:
- Canagliflozin Impurity 48
- Chemical Name:
- Canagliflozin Impurity 54
- Chemical Name:
- Atracurium Impurity 33
- Chemical Name:
- Tofacitinib Impurity 105
- Chemical Name:
- Cabozantinib impurity Q
- Structure:
- Chemical Name:
- Gadobutrol Impurity 1
- CAS:
- 216670-14-3
- MF:
- C22H42ClLiN4O6
- Chemical Name:
- Pemetrexed disodium EP Impurity B
- Chemical Name:
- Crisaborole Impurity 7
- Structure:
- Chemical Name:
- Valnemulin EP Impurity A
- CAS:
- 1624614-06-7
- MF:
- C31H52N2O6S
- Chemical Name:
- Olprinone Impurity F
- Chemical Name:
- Nicorandil Impurity E
- Chemical Name:
- Prednicarbate Impurity G
- Chemical Name:
- Anastrozole iMpurity F
- Chemical Name:
- Ondansetron IMpurity 6
- Chemical Name:
- MeropeneM iMpurity 6
- Structure:
- Chemical Name:
- Macitentan Impurity 33
- CAS:
- 2089065-77-8
- MF:
- C28H32Br2N8O6S2
- Chemical Name:
- Cefminox Impurity 5
- Chemical Name:
- Alogliptin Impurity 27
- Chemical Name:
- Alogliptin Impurity 20
- Structure:
- Chemical Name:
- Cyclobenzaprine Impurity 3
- CAS:
- 24167-44-0
- MF:
- C15H11BrO
- Structure:
- Chemical Name:
- Emtricitabine Impurity 16
- CAS:
- 1160303-44-5
- MF:
- C8H10FN3O4S
- Chemical Name:
- Etoricoxib Impurity 44
- Structure:
- Chemical Name:
- Irbesartan Impurity 15
- MF:
- C25H28N6O
- Chemical Name:
- Linagliptin Impurity 54
- Chemical Name:
- Ornidazole Impurity 13
- Chemical Name:
- Oseltamivir Impurity 44
- Chemical Name:
- Oseltamivir Impurity 51
- Chemical Name:
- Palbociclib Impurity 47
- Chemical Name:
- Rosuvastatin Impurity 98
- Structure:
- Chemical Name:
- Sildenafil Impurity 38
- MF:
- C22H30N6O4S
- Chemical Name:
- Tenofovir Impurity 70
- Chemical Name:
- Ticagrelor Impurity 122
- Structure:
- Chemical Name:
- Tofacitinib Impurity 111
- CAS:
- 2374700-37-3
- MF:
- C27H31N5O2S
- Chemical Name:
- Trelagliptin Impurity 41
- Chemical Name:
- Carbocistein Impurity D
- Structure:
- Chemical Name:
- Ranitidine impurity F
- MF:
- C13H22N4O3S
- Chemical Name:
- Beclometasone Impurity B
- Structure:
- Chemical Name:
- (3R)-Nmethyl-3-(3-methylphenoxy)-3-phenylpropan-1-amine
- CAS:
- 1643684-05-2
- MF:
- C17H22ClNO
- Chemical Name:
- Caspofungin Impurity 6
- Structure:
- Chemical Name:
- Erythromycin Impurity 3
- CAS:
- 1357466-70-6
- MF:
- C38H69N3O13S