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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 CAS MF
phenyl (R)-methyl(3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl)carbamate phenyl (R)-methyl(3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propyl)carbamate 603996-87-8 C8H11NO2S
Aprepitant Impurity 23 Aprepitant Impurity 23
Canagliflozin impurity H Canagliflozin impurity H
Cefazolin Impurity 9 Cefazolin Impurity 9 1322626-65-2 C14H15N9O3S3
Dapagliflozin Impurity 20 Dapagliflozin Impurity 20 2040305-09-5 C29H33ClO10
Edaravone Impurity 10 Edaravone Impurity 10 710307-89-4 C10H12N2O2
Empagliflozin Impurity 23 Empagliflozin Impurity 23
Entecavir Impurity 3 Entecavir Impurity 3 1391053-94-3 C12H15N5O4
IBrutinib Impurity C IBrutinib Impurity C
Imatinib impurity 12 Imatinib impurity 12
Isavuconazole Impurity 20 Isavuconazole Impurity 20
Isavuconazole Impurity 26 Isavuconazole Impurity 26
Istradefylline impurity D Istradefylline impurity D
Leuprorelin EP Impurity F Leuprorelin EP Impurity F 1872435-00-1 C59H84N16O12
Linagliptin Impurity 40 Linagliptin Impurity 40
Minocycline N-Hydroxymethyl Impurity Minocycline N-Hydroxymethyl Impurity 1075240-33-3 C24H29N3O8
Mivacurium Chloride Impurity 3 Mivacurium Chloride Impurity 3 740777-60-0 C33H46NO9+
Mupirocin EP Impurity E Mupirocin EP Impurity E 71087-96-2 C26H44O9
N-Acetyl-Phe-Octreotide N-Acetyl-Phe-Octreotide 83795-61-3 C51H68N10O11S2
Nifuratel Impurity 7 Nifuratel Impurity 7
Norepinephrine EP Impurity D Norepinephrine EP Impurity D 1932110-67-2 C9H13NO3
Olaparib Impurity 4 Olaparib Impurity 4
Paclitaxel EP Impurity M Paclitaxel EP Impurity M
Parecoxib Sodium Impurity H Parecoxib Sodium Impurity H 501093-49-8 C16H14N2O4S
Posaconazole Impurity 10 Posaconazole Impurity 10
Posaconazole Impurity 63 Posaconazole Impurity 63 208187-15-9 C20H26F2O4
(S)-4,5,6,7-Tetrahydro-N2,N6-propionyl-2,6-benzothiazolediaMine (S)-4,5,6,7-Tetrahydro-N2,N6-propionyl-2,6-benzothiazolediaMine 1373869-91-0 C11H17N3O2
SofosBuvir impurity 62 SofosBuvir impurity 62
Tamoxifen EP Impurity E Tamoxifen EP Impurity E C26H29NO
Tenofovir impurity P Tenofovir impurity P
Tirofiban Impurity 3 Tirofiban Impurity 3 1346918-32-8 C13H19NO5S
Trelagliptin Impurity 19 Trelagliptin Impurity 19
N-((3R,4R)-1-(2-cyanoacetyl)-4-methylpiperidin-3-yl)-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine oxide N-((3R,4R)-1-(2-cyanoacetyl)-4-methylpiperidin-3-yl)-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine oxide 2028267-73-2 C16H20N6O2
D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-methoxyphenyl)methyl]phenyl]-, (1S)- D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-methoxyphenyl)methyl]phenyl]-, (1S)- 333359-90-3 C20H23ClO6
Flucloxacillin Sodium Impurity E Flucloxacillin Sodium Impurity E
Amifostine Impurity 1 Amifostine Impurity 1
Clindamycin Phosphate EP Impurity H Clindamycin Phosphate EP Impurity H
2-Thia-5-azabicyclo[2.2.1]heptane-5-carboxylic acid, 3-oxo-, (4-nitrophenyl)methyl ester, (1S,4S)- 2-Thia-5-azabicyclo[2.2.1]heptane-5-carboxylic acid, 3-oxo-, (4-nitrophenyl)methyl ester, (1S,4S)- 151072-00-3 C13H12N2O5S
Brexpiprazole Impurity Brexpiprazole Impurity 2116542-21-1 C38H40N4O4S
4-(1-(2,3-dimethylphenyl)propyl)-1H-imidazole 4-(1-(2,3-dimethylphenyl)propyl)-1H-imidazole 86347-62-8 C14H18N2
Atomoxetine EP Impurity A Atomoxetine EP Impurity A 873310-33-9 C16H20ClNO
Famciclovir Impurity 12 Famciclovir Impurity 12 122497-20-5 C12H15N5O4
Levofloxacin Impurity 22 Levofloxacin Impurity 22 177472-29-6 C20H25F2N3O4
Methylprednisolone EP Impurity E Methylprednisolone EP Impurity E 229019-44-7 C21H28O4
Pantoprazole Impurity 1 Pantoprazole Impurity 1 812664-93-0 C16H14ClF2N3O4S
Ticagrelor Related Compound 38D-Tartrate Ticagrelor Related Compound 38D-Tartrate 2165881-71-8 C10H19NO4
1-(1-BENZOTHIOPHEN-7-YL)PIPERAZINE 1-(1-BENZOTHIOPHEN-7-YL)PIPERAZINE 105685-06-1 C12H14N2S
4-methyl-N-(2-methyl-5-nitrophenyl)-6-(pyridin-3-yl)pyrimidin-2-amine 4-methyl-N-(2-methyl-5-nitrophenyl)-6-(pyridin-3-yl)pyrimidin-2-amine C17H15N5O2
Afatinib Impurity 21 Afatinib Impurity 21 2044709-72-8 C18H16F2N4O2
trans-Carboprost trans-Carboprost 76498-29-8 C21H36O5
N-[[2-(1H-Tetrazol-5-Yl)[1,1-Biphenyl]-4-Yl]Methyl]Amine(WXC00176) N-[[2-(1H-Tetrazol-5-Yl)[1,1-Biphenyl]-4-Yl]Methyl]Amine(WXC00176) 147225-68-1 C14H13N5
Atracurium Impurity 26 Atracurium Impurity 26
Aztreonam Impurity 2 Aztreonam Impurity 2
Benazepril Impurity E Benazepril Impurity E C24H28N2O5
Canagliflozin Impurity 44 Canagliflozin Impurity 44
Clotrimazole Impurity 3 Clotrimazole Impurity 3
Dithio-Desethyl Carbodenafil Dithio-Desethyl Carbodenafil 1610830-81-3 C22H28N6OS2
Erlotinib Impurity 57 Erlotinib Impurity 57
Esomeprazole Impurity 41 Esomeprazole Impurity 41
Oseltamivir Impurity 29 Oseltamivir Impurity 29
Pramipexole Impurity 36 Pramipexole Impurity 36
Riboflavin Impurity 1 Riboflavin Impurity 1 64480-68-8 C16H20N2O7
Rocuronium Bromide Impurity 10 Rocuronium Bromide Impurity 10
Rocuronium Bromide Impurity 23 Rocuronium Bromide Impurity 23 C23H39NO3
Adefovir Impurity 10 Adefovir Impurity 10
Apremilast Impurity SY Apremilast Impurity SY
Atracurium Impurity L Atracurium Impurity L
Cefoxitin EP Impurity G Cefoxitin EP Impurity G
Dextrorotation lansoprazole Impurity L Dextrorotation lansoprazole Impurity L
lansoprazole Impurity 25 lansoprazole Impurity 25
Mirabegron Enantiomer Impurity Mirabegron Enantiomer Impurity
Ropivacaine Impurity 44 Ropivacaine Impurity 44
Ropivacaine Impurity 7 Ropivacaine Impurity 7
Sugammadex sodium Org199010-1 Impurity Sugammadex sodium Org199010-1 Impurity
Sugammadex sodium Org226100-1 Impurity Sugammadex sodium Org226100-1 Impurity
Afatinib impurity 32 Afatinib impurity 32
Butyphthalide impurity 26 Butyphthalide impurity 26
Butyphthalide impurity 32 Butyphthalide impurity 32
Canagliflozin Impurity 30 Canagliflozin Impurity 30
Celecoxib Impurity 20 Celecoxib Impurity 20 343853-74-7 C6H7N3O3S
Emtricitabine Impurity CFTU1 Emtricitabine Impurity CFTU1
Esomeprazole Impurity 34 Esomeprazole Impurity 34
Febuxostat Impurity 82 Febuxostat Impurity 82
Febuxostat Impurity 87 Febuxostat Impurity 87
Gefitinib Impurity R Gefitinib Impurity R
Imatinib impurity 31 Imatinib impurity 31 1356565-47-3 C17H17N7
LCZ696(valsartan + sacubitril) impurity 33 LCZ696(valsartan + sacubitril) impurity 33
Lenvatinib Impurity 26 Lenvatinib Impurity 26
Ozagrel impurity C Ozagrel impurity C
Regorafenib Impurity 24 Regorafenib Impurity 24
Regorafenib Impurity 32 Regorafenib Impurity 32
Sitafloxacin Impurity ZZ-A-01 Sitafloxacin Impurity ZZ-A-01
Solifenacin impurity 18 Solifenacin impurity 18 1243274-83-0 C14H17NO3
Tofacitinib Impurity 87 Tofacitinib Impurity 87
Tofacitinib Impurity 92 Tofacitinib Impurity 92
Amlodipine EP Impurity K Amlodipine EP Impurity K C26H31ClN2O8S
Febuxostat Impurity 49 Febuxostat Impurity 49
Budesonide Impurity 6 Budesonide Impurity 6 131918-73-5 C21H26O6
Timolol Impurity 1 Timolol Impurity 1 75014-25-4 C13H24N4O5S
Telmisartan EP-J Telmisartan EP-J 885045-90-9 C33H29ClN4O2
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