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:
- 5-(hydroxymethyl)-1,2-dihydro-1,2,4-triazol-3-one
- CAS:
- 24021-90-7
- MF:
- C3H5N3O2
- Structure:
- Chemical Name:
- ( 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}acetic acid tert-butylester )
- CAS:
- 475084-96-9
- MF:
- C29H37N3O3
- Structure:
- Chemical Name:
- N-(4-Hydroxymethylbenzyl) Cyclam
- CAS:
- 176252-20-3
- MF:
- C18H32N4O
- Chemical Name:
- Alvimopan Impurity 3
- Chemical Name:
- Nicergoline Impurity G
- Structure:
- Chemical Name:
- Isavuconazole Impurity 1
- CAS:
- 2069200-13-9
- MF:
- C13H12F2N4O
- Chemical Name:
- Sofosbuvir Impurity23
- Chemical Name:
- Tacrolimus Impurity 1
- Structure:
- Chemical Name:
- Bisoprolol EP Impurity F
- CAS:
- 1798418-82-2
- MF:
- C18H31NO4
- Structure:
- Chemical Name:
- Pantoprazole EP Impurity F
- CAS:
- 721924-06-7
- MF:
- C17H17F2N3O4S
- Chemical Name:
- Rosuvastatin EP Impurity E
- Structure:
- Chemical Name:
- Tiotropium EP Impurity C
- CAS:
- 136310-95-7
- MF:
- C19H22BrNO3S2
- Structure:
- Chemical Name:
- Eliglustat intermediate 4
- CAS:
- 491833-27-3
- MF:
- C23H30N2O4
- Structure:
- Chemical Name:
- 2-[(4-Acetylphenyl)methyl]cyclopentan-1-one
- CAS:
- 96824-28-1
- MF:
- C14H16O2
- Structure:
- Chemical Name:
- Dapoxetine Impurity 1
- CAS:
- 119357-22-1
- MF:
- C22H25NO
- Chemical Name:
- Mirabegron Impurity 5
- Chemical Name:
- Milrinone Impurity 5
- Structure:
- Chemical Name:
- Solifenacin Related Compound 20
- CAS:
- 1300713-32-9
- MF:
- C17H17NO
- Structure:
- Chemical Name:
- 4-Acetoxyisophthalic Acid
- CAS:
- 5985-26-2
- MF:
- C10H8O6
- Structure:
- Chemical Name:
- Ganciclovir Dipropionate
- CAS:
- 86357-20-2
- MF:
- C15H21N5O6
- Structure:
- Chemical Name:
- IMp. A (EP): (RS)-2-Chloro-N-(2-Methylphenyl)-PropanaMide
- CAS:
- 39084-88-3
- MF:
- C10H11Cl2NO
- Structure:
- Chemical Name:
- L-Alanine, N-[(2,3,4,5,6-pentafluorophenoxy)phenoxyphosphinyl]-, 1-Methylethyl ester
- CAS:
- 1256490-52-4
- MF:
- C18H17F5NO5P
- Structure:
- Chemical Name:
- Ondansetron impurity G (PhEur)
- CAS:
- 99614-04-7
- MF:
- C17H18ClN3O
- Structure:
- Chemical Name:
- 4-Hydroxy-1-methyl-7-phenoxy-3-isoquinolinecarboxylic acid methyl ester
- CAS:
- 1421312-34-6
- MF:
- C18H15NO4
- Structure:
- Chemical Name:
- 2-[(4-METHYLPHENOXY)METHYL]BENZOIC ACID
- CAS:
- 728-97-2
- MF:
- C15H14O3
- Structure:
- Chemical Name:
- Cefuroxime Impurity 2
- MF:
- C16H16N4O8S
- Chemical Name:
- Cefoxitin Impurity 1
- Chemical Name:
- Cefazolin Impurity 1
- Structure:
- Chemical Name:
- Umeclidinium Bromide Impurity 8
- CAS:
- 869113-10-0
- MF:
- C27H30BrNO
- Chemical Name:
- Nifuratel impurity E
- Structure:
- Chemical Name:
- Valsartan Impurity 14
- MF:
- C24H29N5O3
- Chemical Name:
- Istradefylline Impurity 4
- Chemical Name:
- Zolmitriptan Impurity 2
- Structure:
- Chemical Name:
- Atazanavir Impurity 6
- CAS:
- 1006868-81-0
- MF:
- C32H42N4O5
- Structure:
- Chemical Name:
- Palbociclib Impurity 9
- CAS:
- 2204368-66-9
- MF:
- C24H29N7O2
- Structure:
- Chemical Name:
- Solifenacin Impurity 1
- CAS:
- 1353274-25-5
- MF:
- C19H21NO2
- Chemical Name:
- Vildagliptin Methyl Ester
- Chemical Name:
- Flucloxacillin Impurity B
- Chemical Name:
- Ropinirole impurity
- Structure:
- Chemical Name:
- Mupirocin iMpurity B
- MF:
- C26H44O9
- Chemical Name:
- Nicorandil Impurity 2
- Chemical Name:
- Piperacillin Impurity 7
- Chemical Name:
- Defluoro Paroxetine Hydrochloride
- CAS:
- 1394842-91-1
- Chemical Name:
- Afatinib Impurity 15
- Structure:
- Chemical Name:
- Milnacipran Impurity 11
- CAS:
- 1410831-12-7
- MF:
- C11H10O2
- Chemical Name:
- Mirabegron Impurity 18
- Structure:
- Chemical Name:
- Atorvastatin lactone
- CAS:
- 125995-03-1
- MF:
- C33H33FN2O4
- Structure:
- Chemical Name:
- Prucalopride Impurity F
- CAS:
- 1900715-98-1
- MF:
- C18H26ClN3O4
- Structure:
- Chemical Name:
- tert-butyl (R)-3-(hydroxymethyl)hexanoate
- CAS:
- 1928755-17-2
- MF:
- C11H22O3
- Structure:
- Chemical Name:
- Alfuzosin
- CAS:
- 19216-53-6
- MF:
- C12H16N4O2
- Structure:
- Chemical Name:
- 4-[[3-Chloro-4-(2-pyridinylmethoxy)phenyl]amino]-7-ethoxy-6-[(1-methyl-2-pyrrolidinylidene)amino]-3-quinolinecarbonitrile
- CAS:
- 1144516-21-1
- MF:
- C29H27ClN6O2
- Chemical Name:
- Sofosbuvir Impurity 5
- Structure:
- Chemical Name:
- ethyl (S)-2-(2-oxopyrrolidin-1-yl)butanoate
- CAS:
- 1862335-58-7
- MF:
- C9H16ClNO3
- Structure:
- Chemical Name:
- vildagliptin Impurity R
- CAS:
- 1803168-09-3
- MF:
- C7H8Cl2N2O
- Structure:
- Chemical Name:
- 8-Hydroxy Pitavastatin
- CAS:
- 224320-09-6
- MF:
- C25H24FNO5
- Structure:
- Chemical Name:
- α-Decitabine
- CAS:
- 22432-95-7
- MF:
- C8H12N4O4
- Structure:
- Chemical Name:
- Aloin Peracetate
- CAS:
- 64951-96-8
- MF:
- C37H38O17
- Structure:
- Chemical Name:
- Tinnevellin glucoside
- CAS:
- 80358-06-1
- MF:
- C20H24O9
- Chemical Name:
- Cefditoren iMpurity 2, Cefditoren open ring
- Chemical Name:
- Ceftriaxone IMpurity C
- Chemical Name:
- Etoricoxib iMpurity 2
- Structure:
- Chemical Name:
- Lorcaserin iMpurity D
- CAS:
- 1030624-36-2
- MF:
- C11H14ClNO2
- Chemical Name:
- Ticagrelor IMpurity L (Mixture of DiastereoMers)
- Structure:
- Chemical Name:
- α-Hydroxy-α-3-thienyl-2-thiopheneacetic Acid 9-Methyl-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl Ester
- CAS:
- 783273-13-2
- MF:
- C18H19NO4S2
- Structure:
- Chemical Name:
- 3H-4,7a-Methanocyclohept[3,3a]indeno[5,4-b]oxete Benzenepropanoic Acid Derivative
- CAS:
- 146139-03-9
- MF:
- C47H51NO14
- Structure:
- Chemical Name:
- Fluvastatin 3-Hydroxy-4,6-diene
- CAS:
- 1207963-21-0
- MF:
- C24H24FNO3
- Chemical Name:
- Cyclosporine iMpurity
- Structure:
- Chemical Name:
- ThiaMine IMpurity
- MF:
- C12H17ClN4OS
- Chemical Name:
- CitalopraM IMpurity
- Structure:
- Chemical Name:
- 3-(5-Methyl-3-phenylisoxazol-4-yl)benzenesulfonaMide
- MF:
- C16H14N2O3S
- Chemical Name:
- Tigecycline
- Structure:
- Chemical Name:
- 1-((2R,3R,4R,5R)-3-chloro-4-hydroxy-5-(hydroxyMethyl)-3-Methyltetrahydrofuran-2-yl)pyriMidine-2,4(1H,3H)-dione
- CAS:
- 1496551-72-4
- MF:
- C10H13ClN2O5
- Structure:
- Chemical Name:
- 1-NaphthaleneMethanaMine, 7,8-dihydro-α-Methyl-N-[3-[3-(trifluoroMethyl)phenyl]propyl]-, hydrochloride (1:1), (αR)-
- CAS:
- 1020414-33-8
- MF:
- C22H25ClF3N
- Structure:
- Chemical Name:
- 4,6-dichloro-2-(propylsulfinyl)pyriMidin-5-aMine
- CAS:
- 1823431-32-8
- MF:
- C7H9Cl2N3OS
- Structure:
- Chemical Name:
- Acetic acid, [[(3aR,4S,6R,6aS)-tetrahydro-2,2-diMethyl-6-[[(phenylMethoxy)carbonyl]aMino]-4H-cyclopenta-1,3-dioxol-4-yl]oxy]-, ethyl ester
- CAS:
- 866551-95-3
- MF:
- C20H27NO7
- Structure:
- Chemical Name:
- 4',6'-Dinitro-2'-phenoxymethanesulfonanilide
- CAS:
- 51765-56-1
- MF:
- C13H11N3O7S
- Structure:
- Chemical Name:
- 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylic acid methyl ester hydrochloride
- CAS:
- 33778-93-7
- MF:
- C20H26ClNO4
- Chemical Name:
- Blonanserin Impurity I
- Structure:
- Chemical Name:
- 25,26,26,26,27,27-hexadeuterocholest-5-ene-3,27-diol
- CAS:
- 1246302-95-3
- MF:
- C27H40D6O2
- Structure:
- Chemical Name:
- 2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2R)-2-aMino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-, (1R,3R,5R)-
- CAS:
- 1564265-95-7
- MF:
- C18H25N3O2
- Structure:
- Chemical Name:
- (1S,5R,6R)-5-Hydroxy-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Ethyl Ester
- CAS:
- 876014-27-6
- MF:
- C9H12O4
- Structure:
- Chemical Name:
- (3R,5R)-Rosuvastatin Lactone
- CAS:
- 1422954-11-7
- MF:
- C22H26FN3O5S
- Structure:
- Chemical Name:
- EMpagliflozin iMpurity 10
- CAS:
- 2069942-68-1
- MF:
- C32H37ClO12
- Chemical Name:
- EMpagliflozin iMpurity 15
- Structure:
- Chemical Name:
- (S)-8-(3-aMinopiperidin-1-yl)-7-(but-2-ynyl)-3-Methyl-1-((4-Methylquinazolin-2-yl)Methyl)-1H-purine-2,6(3H,7H)-dione
- CAS:
- 668269-51-0
- MF:
- C25H28N8O2
- Chemical Name:
- ibrutinib iMpurity B
- Chemical Name:
- Sunitinib iMpurity A
- Chemical Name:
- Sunitinib iMpurity F
- Structure:
- Chemical Name:
- (3R,4S)-1-(3-fluorophenyl)-3-((S)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one
- CAS:
- 1700622-06-5
- MF:
- C24H21F2NO3
- Structure:
- Chemical Name:
- Betamethasone EP Impurity J
- CAS:
- 18383-24-9
- MF:
- C22H30O4
- Structure:
- Chemical Name:
- Cefazedone Related Impurity 10
- CAS:
- 18884-65-6
- MF:
- C10H12N2O5S
- Structure:
- Chemical Name:
- Etoricoxib Impurity 8
- CAS:
- 1421227-97-5
- MF:
- C22H20N2O4S
- Structure:
- Chemical Name:
- Mupirocin Impurity E
- MF:
- C26H44O9
- Structure:
- Chemical Name:
- Phenylephrine Impurity 1
- MF:
- C9H13NO2
- Structure:
- Chemical Name:
- Rupatadine Impurity B
- CAS:
- 156523-04-5
- MF:
- C26H24ClN3O
- Structure:
- Chemical Name:
- Theophylline Impurity 1
- CAS:
- 5614-53-9
- MF:
- C9H10N4O3
- Structure:
- Chemical Name:
- Venlafaxine N-Dimer
- CAS:
- 1187545-61-4
- MF:
- C32H48N2O4
- Structure:
- Chemical Name:
- Chrysin 6-C-glucoside 8-C-arabinoside
- CAS:
- 185145-34-0
- MF:
- C26H28O13
- Structure:
- Chemical Name:
- ent-Ivabradine Hydrochloride
- CAS:
- 148849-68-7
- MF:
- C27H37ClN2O5
- Structure:
- Chemical Name:
- Sofosbuvir metabolites GS566500
- CAS:
- 1233335-78-8
- MF:
- C13H19FN3O9P