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-(6-chloro-5-fluoropyrimidin-4-yl)ethanol
- CAS:
- 1289559-76-7
- MF:
- C6H6ClFN2O
- Structure:
- Chemical Name:
- Fluoxetine Impurity 29,methyl({3-phenyl-3-[2-(trifluoromethyl)phenoxy]propyl})amine
- CAS:
- 56161-71-8
- MF:
- C17H18F3NO
- Chemical Name:
- (Z)-4-chloro-6-(3-(2,4-difluorophenyl)-4-(1H-1,2,4-triazol-1-yl)but-3-en-2-yl)-5-fluoropyrimidine
- Chemical Name:
- Ceftriaxone sodium impurity 09
- Structure:
- Chemical Name:
- Cefradine Impurity 8
- CAS:
- 30959-67-2
- MF:
- C16H19N3O4S
- Structure:
- Chemical Name:
- Dobutamine Impurity 3
- CAS:
- 334947-75-0
- MF:
- C19H25NO3
- Structure:
- Chemical Name:
- Dobutamine Impurity 3
- CAS:
- 334947-75-0
- MF:
- C19H25NO3
- Structure:
- Chemical Name:
- Dobutamine Impurity 3
- CAS:
- 334947-75-0
- MF:
- C19H25NO3
- Structure:
- Chemical Name:
- Anastrozole Impurity 19
- CAS:
- 1301724-97-9
- MF:
- C19H21N3O2
- Structure:
- Chemical Name:
- Biotin Impurity
- CAS:
- 171232-73-8
- MF:
- C19H18N2O2S
- Structure:
- Chemical Name:
- 5-Carboxy-2'-deoxyuridine
- CAS:
- 14599-46-3
- MF:
- C10H12N2O7
- Structure:
- Chemical Name:
- 2-Desisopropyl-2-phenyl Repaglinide
- CAS:
- 107362-12-9
- MF:
- C30H34N2O4
- 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
- Chemical Name:
- Flucloxacillin sodium EP Impurity E
- Chemical Name:
- Pyrazole
- Chemical Name:
- Cephalomannine (Paclitaxel Impurity I)
- 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:
- Ibuprofen Alcohol
- CAS:
- 36039-36-8
- MF:
- C13H20O
- Chemical Name:
- Sugammadex sodium Impurity 52
- Chemical Name:
- Sugammadex sodium Impurity 43
- Chemical Name:
- Sugammadex sodium Impurity 39
- Structure:
- Chemical Name:
- Apixaban Impurity 52
- CAS:
- 1620494-31-6
- MF:
- C31H29N5O4
- Chemical Name:
- Cefazolin Impurity EP-J
- Chemical Name:
- Cabozantinib impurity 41
- Chemical Name:
- Cabozantinib impurity 67
- Structure:
- Chemical Name:
- ethyl 6-bromo-2-(bromomethyl)-5-hydroxy-1-methyl-1H-indole-3-carboxylate
- CAS:
- 149246-36-6
- MF:
- C13H13Br2NO3
- Chemical Name:
- Dapoxetine impurity 50
- Chemical Name:
- Doxofylline Impurity 18
- Chemical Name:
- Dapoxetine impurity 63
- Chemical Name:
- Dapoxetine impurity 57
- Structure:
- Chemical Name:
- Bosutinib Impurity 2 (N-Desmethyl Bosutinib)
- CAS:
- 380843-81-2
- MF:
- C25H27Cl2N5O3
- Structure:
- Chemical Name:
- 4-PYRIDINECARBOXIMIDIC ACID, HYDRAZIDE
- CAS:
- 89830-71-7
- MF:
- C6H8N4
- 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
- Structure:
- Chemical Name:
- 2-[4-(3-CHLORO-2-HYDROXYPROPOXY)PHENYL]ACETAMIDE
- CAS:
- 115538-83-5
- MF:
- C11H14ClNO3
- Structure:
- Chemical Name:
- 1,1-BIS-(4-ISOBUTYLPHENYL)ETHANE
- CAS:
- 102120-87-6
- MF:
- C22H30
- Structure:
- Chemical Name:
- 4-[(1,3-Dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]-benzamide
- CAS:
- 1187188-59-5
- MF:
- C14H12BNO4
- Structure:
- Chemical Name:
- 2-Propenoic acid, 3-[4-(hydroxymethyl)phenyl]-
- CAS:
- 219915-41-0
- MF:
- C10H10O3
- Structure:
- Chemical Name:
- L-Alanine, 3-[(R)-(carboxymethyl)sulfinyl]-
- CAS:
- 61475-35-2
- MF:
- C5H9NO5S
- Structure:
- Chemical Name:
- Phenol, 2-(2-phenyldiazenyl)-
- CAS:
- 2362-57-4
- MF:
- C12H10N2O
- Structure:
- Chemical Name:
- 3-Quinolinecarboxylic acid, 1-cyclopropyl-7-fluoro-1,4-dihydro-6,8-dimethoxy-4-oxo-
- CAS:
- 2410658-30-7
- MF:
- C15H14FNO5
- Structure:
- Chemical Name:
- Hexanoic acid, 3-(hydroxymethyl)-
- CAS:
- 81381-87-5
- MF:
- C7H14O3
- Structure:
- Chemical Name:
- 1-Pyrrolidinecarboxylic acid, 3,3'-dithiobis[5-[(dimethylamino)carbonyl]-, 1,1'-bis[(4-nitrophenyl)methyl] ester, (3S,3'S,5S,5'S)-
- CAS:
- 936226-36-7
- MF:
- C30H36N6O10S2
- Structure:
- Chemical Name:
- D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[[4-(1-methylethoxy)phenyl]methyl]phenyl]-, (1S)-
- CAS:
- 946525-39-9
- MF:
- C22H27ClO6
- Chemical Name:
- Topiroxostat Impurity 42
- Structure:
- Chemical Name:
- Crisaborole intermediate
- CAS:
- 1187188-60-8
- MF:
- C14H13BO4
- Chemical Name:
- Regorafenib Impurity MHY
- Structure:
- Chemical Name:
- 2-Thiazolamine, 5-(4-cyclohexyl-1-piperazinyl)-4-(4,5-dichloro-2-thienyl)-
- CAS:
- 570407-63-5
- MF:
- C17H22Cl2N4S2
- Structure:
- Chemical Name:
- INDEX NAME NOT YET ASSIGNED
- CAS:
- 2417213-74-0
- MF:
- C42H42N4O12S
- Structure:
- Chemical Name:
- Lumateperone Impurity 6
- CAS:
- 313368-82-0
- MF:
- C23H26FN3O
- Structure:
- Chemical Name:
- 1H-?Indole-?5,?6-?diol, 1-?[3-?(4-?hydroxyphenyl)?-?1-?methylpropyl]?-
- CAS:
- 2514709-72-7
- MF:
- C18H19NO3
- Structure:
- Chemical Name:
- 1H-?Indole-?5,?6-?diol, 1-?[3-?(4-?hydroxyphenyl)?-?1-?methylpropyl]?-
- CAS:
- 2514709-72-7
- MF:
- C18H19NO3
- Structure:
- Chemical Name:
- 4-Pyrimidineethanol, 6-bromo-α-(2,4-difluorophenyl)-5-fluoro-β-methyl-α-(1H-1,2,4-triazol-1-ylmethyl)-
- CAS:
- 1307315-04-3
- MF:
- C16H13BrF3N5O
- Structure:
- Chemical Name:
- Cycloocta[b]pyridine, 2-(4-ethyl-1,4-dioxido-1-piperazinyl)-4-(4-fluorophenyl)-5,6,7,8,9,10-hexahydro-
- CAS:
- 2247538-61-8
- MF:
- C23H30FN3O2
- Structure:
- Chemical Name:
- Apremilast Impurity 84
- CAS:
- 2096492-43-0
- MF:
- C22H24N2O8S
- Structure:
- Chemical Name:
- Apremilast Impurity 84
- CAS:
- 2096492-43-0
- MF:
- C22H24N2O8S
- Structure:
- Chemical Name:
- Apremilast Impurity 84
- CAS:
- 2096492-43-0
- MF:
- C22H24N2O8S
- Chemical Name:
- Vonoprazan Impurity B-3
- Structure:
- Chemical Name:
- 3-Azetidineacetamide, 1-(ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl]-
- CAS:
- 2271228-51-2
- MF:
- C16H19N7O3S
- Chemical Name:
- Budesonide Impurity 26
- Chemical Name:
- Peramivir Impurity 48
- Chemical Name:
- Tolvaptan dehydroxylated impurity
- Structure:
- Chemical Name:
- 3-Quinolinemethanol, 2-cyclopropyl-4-phenyl-
- CAS:
- 2153433-73-7
- MF:
- C19H17NO
- Chemical Name:
- Avatrombopag Impurity 37
- Chemical Name:
- Piperacillin ImpurityABCDEFGHI
- Structure:
- Chemical Name:
- 5,6-DIMETHOXY-2-PYRIDIN-4-YLMETHYL-INDAN-1-ONE
- CAS:
- 4803-57-0
- MF:
- C17H17NO3