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.
- Chemical Name:Clindamycin Impurity 17
- CAS:
- MF:
- Structure:

- Chemical Name:Edaravone Impurity 12
- CAS:2061958-41-4
- MF:C12H16N2O2
- Chemical Name:Empagliflozin Impurity 19
- CAS:
- MF:
- Chemical Name:Erythromycin impurity D
- CAS:
- MF:
- Chemical Name:FeBuxostat Impurity 40
- CAS:
- MF:
- Structure:

- Chemical Name:Formoterol Impurity 13
- CAS:150513-24-9
- MF:C18H24N2O3
- Structure:

- Chemical Name:Fosaprepitant Impurity 4
- CAS:1523569-85-8
- MF:C37H34F7N4O6P
- Structure:

- Chemical Name:Fudosteine Impurity 2
- CAS:1480319-53-6
- MF:C6H13NO5S
- Chemical Name:Ilaprazole Impurity 1
- CAS:
- MF:
- Chemical Name:Ilaprazole Impurity 2
- CAS:
- MF:
- Chemical Name:Isavuconazole Impurity 10
- CAS:
- MF:
- Chemical Name:Isavuconazole Impurity 18
- CAS:3094994-77-8
- MF:
- Chemical Name:Isavuconazole Impurity 6
- CAS:
- MF:
- Structure:

- Chemical Name:Lercanidipine Impurity 4
- CAS:2727061-30-3
- MF:C18H23NO2
- Structure:

- Chemical Name:Minocycline 5,6a-Dehydro Impurity
- CAS:1346598-44-4
- MF:C23H25N3O7
- Chemical Name:Nitrendipine Impurity 4
- CAS:
- MF:
- Chemical Name:Olaparib Impurity 6
- CAS:
- MF:
- Chemical Name:Paclitaxel EP Impurity H
- CAS:
- MF:
- Chemical Name:Lasmiditan Impurity 9
- CAS:
- MF:
- Structure:

- Chemical Name:L-erythro-3-(3,4-Dihydroxyphenyl)serine
- CAS:34047-62-6
- MF:C9H11NO5
- Chemical Name:(S)-6-(benzyloxy)-8-(oxiran-2-yl)-2H-benzo[b][1,4]oxazin-3(4H)-one
- CAS:
- MF:
- Chemical Name:Odaterol Impurity 35
- CAS:
- MF:
- Chemical Name:Imimidistine impurity I
- CAS:
- MF:
- 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)
- CAS:
- MF:
- 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:7-Phenyl-acetamido-deacetoxy-cephalosporanic-acid
- CAS:27255-72-7
- MF:C16H16N2O4S
- Structure:

- Chemical Name:O-Propionylbenzoic acid
- CAS:2360-45-4
- MF:C10H10O3
- Chemical Name:Paroxetine Impurity 10
- CAS:
- MF:
- Chemical Name:Posaconazole Impurity 31
- CAS:
- MF:
- Structure:

- Chemical Name:Posaconazole Impurity 60
- CAS:2134652-05-2
- MF:C14H14F2O4
- Chemical Name:Regorafenib impurity D
- CAS:
- MF:
- Structure:

- Chemical Name:SofosBuvir impurity 21
- CAS:1496552-50-1
- MF:C22H29ClN3O9P
- Chemical Name:sofosBuvir impurity 36
- CAS:
- MF:
- Chemical Name:SofosBuvir Impurity 52
- CAS:
- MF:
- Chemical Name:SofosBuvir Impurity 59
- CAS:
- MF:
- Chemical Name:Ticagrelor impurity 25
- CAS:
- MF:
- Structure:

- Chemical Name:Tirofiban Impurity 14
- CAS:1103300-75-9
- MF:C12H17NO5S
- Structure:

- Chemical Name:Tirofiban Impurity 19
- CAS:158808-75-4
- MF:C18H28N2O3
- Chemical Name:Anastrozole Impurity 13
- CAS:
- MF:
- Chemical Name:Cefotiam impurity 07
- CAS:
- MF:
- Structure:

- Chemical Name:benzo-1,3-dioxol-5-ol acetate
- CAS:326-58-9
- MF:C9H8O4
- Structure:

- Chemical Name:2-((4R,6S)-6-(chloromethyl)-2,2-dimethyl- 1,3-dioxan-4-yl)acetic acid
- CAS:775571-58-9
- MF:C9H15ClO4
- Structure:

- Chemical Name:Ruxolitinib Impurity 1
- CAS:3027185-21-0
- MF:C25H29N7
- Chemical Name:Cefradine Impurity L
- CAS:
- MF:
- Structure:

- Chemical Name:(8beta)-10methoxy-6-dimethylergoline-8-methanol-5-bromo-3-pyridinecarboxylate(ester)
- CAS:35264-46-1
- MF:C23H24BrN3O3
- Chemical Name:Cephalexin Open-Ring Impurity
- CAS:
- MF:
- Chemical Name:Oxacillin sodium EP impurity J
- CAS:
- MF:
- Chemical Name:Piperacillin Sodium EP Impurity P
- CAS:
- MF:
- Chemical Name:Ertapenem Impurity B(USP)
- CAS:
- MF:
- Structure:

- Chemical Name:INDEX NAME NOT YET ASSIGNED
- CAS:2458312-06-4
- MF:C27H30N2O6
- Structure:

- Chemical Name:15(R)-17-Phenyl trinor prostaglandin f2alpha
- CAS:41639-71-8
- MF:C23H32O5
- Structure:

- Chemical Name:Acetamide, N-(4-hydroxyphenyl)-N-nitroso-
- CAS:146897-60-1
- MF:C8H8N2O3
- Chemical Name:RICE BRAN OIL
- CAS:68553-81-1
- MF:
- Structure:

- Chemical Name:3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-[4-(1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl]-
- CAS:2402776-83-2
- MF:C16H17N7O2S
- Chemical Name:Iohexol ImpuritiesE
- CAS:
- MF:
- Structure:

- Chemical Name:tert-Butyl (R)-6-chloro-5-hydroxy-3-oxohexanoate
- CAS:404958-08-3
- MF:C10H17ClO4
- Chemical Name: Bumetanide Photodegradable Impurity 16
- CAS:
- MF:
- Chemical Name:Letermovir Impurity 2
- CAS:
- MF:
- Structure:

- Chemical Name:1H-Imidazole-2-carboxylic acid
- CAS:16042-25-4
- MF:C4H4N2O2
- Chemical Name:Olodaterol Impurity 19
- CAS:
- MF:
- Chemical Name:Ethacridine Impurity 12
- CAS:
- MF:
- Structure:

- Chemical Name:Mirogabalin Impurity N84
- CAS:2166206-19-3
- MF:C12H19NO2
- 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:7-Didemethyl Minocycline
- CAS:5679-00-5
- MF:C21H23N3O7
- 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:9H-3,9'-bicarbazole-1,1',2,2',3',4,4',5,5',6,6',7,7',8,8'-d15
- CAS:2778147-33-2
- MF:C24H16N2
- Structure:

- Chemical Name:6-Bromo-3 H-isobenzofuran-1-one
- CAS:19477-73-7
- MF:C8H5BrO2
- 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