Glossary entry (derived from question below)
English term or phrase:
HSE
English answer:
in-house specification
Added to glossary by
Charles Davis
May 7, 2016 19:13
8 yrs ago
17 viewers *
English term
HSE
English
Medical
Medical: Pharmaceuticals
Patient Information Leaflet (PIL)
What does HSE stands for in the following context:
Fluticasone Propionate (micronised) HSE 0.05% w/w.
Fluticasone Propionate (micronised) HSE 0.05% w/w.
Responses
4 +6 | in-house specification | Charles Davis |
References
Uk government site | Bashiqa |
? | Helena Chavarria |
Change log
May 21, 2016 08:06: Charles Davis Created KOG entry
Responses
+6
11 hrs
Selected
in-house specification
HSE is an indication that appears after the names of pharmaceutical ingredients (APIs and excipients) in PILs (product information leaflets) and SPCs (summaries of product characteristics). Other analogous indications that appear include BP (British Pharmacopoeia), USP (United States Pharmacopoeia) and Ph Eur (European Pharmacopoeia). Here are a couple of examples:
"1. Name of the medicinal product
Cutivate® 0.05% w/w Cream
2. Qualitative and quantitative composition
Fluticasone Propionate (micronised) HSE 0.05% w/w."
https://www.medicines.org.uk/emc/medicine/726#PRODUCTINFO
"1. Name of the medicinal product
SANDO-K®
2. Qualitative and quantitative composition
Effervescent Tablets containing 0.6g potassium chloride Ph.Eur., 0.4g potassium bicarbonate USP"
https://www.medicines.org.uk/emc/medicine/812
These abbreviations indicate the reference standards: they certify that the ingredient conforms to the specifications of the pharmacopoeia indicated. However, HSE is not the name of a pharmacopoeia. It can be the abbreviation of the Irish Health Services Executive or the UK's Health and Safety Executive, but neither of these is relevant here since neither body certifies the specifications of pharmaceutical ingredients.
HSE means "in-house specification"; it’s used when there is no monograph for the ingredient in question in the usual pharmacopoeias, or where such monographs have not been used.
"HSE - In House Specification"
REGULATORY LEXICON
(Common abbreviations in Regulatory Affairs)
http://www.espl-regulatory.com/reglex-feb2016.pdf
"Active substance not described in a pharmacopoeia
For active substances not described in a pharmacopoeia, the in-house specification
should be provided."
http://lenus.ie/hse/bitstream/10147/96980/1/ProductDossier06...
"Analytical methods used in the laboratories are primarily pharmacopoeial, taken from the British Pharmacopoeia or European Pharmacopoeia or from other international pharmacopoeias as appropriate. However, in many cases no suitable official monograph exists, so in-house specifications are developed and validated."
Martin Stephens, ed., Hospital Pharmacy, p. 103
http://202.74.245.22:8080/xmlui/bitstream/handle/123456789/4...
This one is a bit long, but usefully explicit:
"Ingredient.................................................Ref std
Amoxicillin THD erial) (as trihydrate)......Ph Eur/HSE
Clavulanic acid [...]....................................Ph Eur/HSE
Xanthan gum..............................................Ph Eur/NF
Succinic acid..............................................HSE
Colloidal silicon dioxide............................Ph Eur/USP
[...]
Strawberry powder flavour........................HSE
Orange powder flavour..............................HSE
[...]
EXCIPIENTS
Xanthan gum, colloidal silicon dioxide, saccharin sodium, hydroxypropylmethyl cellulose (hypromellose) and silicon dioxide are specified as complying with published Ph Eur monographs. Xanthan gum, colloidal silicon dioxide and hypromellose are additionally specified as complying with corresponding USP/NF monographs. [...] An ‘in house’ specification for succinic acid has been provided, based on the supplier’s own specification. Satisfactory evidence of compliance has been presented. In-house specifications have also been provided for the strawberry, orange and lemon flavouring agents."
http://www.mhra.gov.uk/home/groups/par/documents/websitereso...
--------------------------------------------------
Note added at 11 hrs (2016-05-08 07:03:15 GMT)
--------------------------------------------------
One more for luck:
" 10 mg tablet
Obeticholic acid 10.0 mg* API HSE
Microcrystalline cellulose 176.0 mg* Filler/Binder USP-NF/EP/JP
[...]
API: Active pharmaceutical ingredient
HSE = In house specification
USP-NF = US Pharmacopeia National Formulary
Ph Eur = European Pharmacopeia
JP =Japanese Pharmacopeia"
http://www.google.com/patents/WO2013192097A1?cl=en
"1. Name of the medicinal product
Cutivate® 0.05% w/w Cream
2. Qualitative and quantitative composition
Fluticasone Propionate (micronised) HSE 0.05% w/w."
https://www.medicines.org.uk/emc/medicine/726#PRODUCTINFO
"1. Name of the medicinal product
SANDO-K®
2. Qualitative and quantitative composition
Effervescent Tablets containing 0.6g potassium chloride Ph.Eur., 0.4g potassium bicarbonate USP"
https://www.medicines.org.uk/emc/medicine/812
These abbreviations indicate the reference standards: they certify that the ingredient conforms to the specifications of the pharmacopoeia indicated. However, HSE is not the name of a pharmacopoeia. It can be the abbreviation of the Irish Health Services Executive or the UK's Health and Safety Executive, but neither of these is relevant here since neither body certifies the specifications of pharmaceutical ingredients.
HSE means "in-house specification"; it’s used when there is no monograph for the ingredient in question in the usual pharmacopoeias, or where such monographs have not been used.
"HSE - In House Specification"
REGULATORY LEXICON
(Common abbreviations in Regulatory Affairs)
http://www.espl-regulatory.com/reglex-feb2016.pdf
"Active substance not described in a pharmacopoeia
For active substances not described in a pharmacopoeia, the in-house specification
should be provided."
http://lenus.ie/hse/bitstream/10147/96980/1/ProductDossier06...
"Analytical methods used in the laboratories are primarily pharmacopoeial, taken from the British Pharmacopoeia or European Pharmacopoeia or from other international pharmacopoeias as appropriate. However, in many cases no suitable official monograph exists, so in-house specifications are developed and validated."
Martin Stephens, ed., Hospital Pharmacy, p. 103
http://202.74.245.22:8080/xmlui/bitstream/handle/123456789/4...
This one is a bit long, but usefully explicit:
"Ingredient.................................................Ref std
Amoxicillin THD erial) (as trihydrate)......Ph Eur/HSE
Clavulanic acid [...]....................................Ph Eur/HSE
Xanthan gum..............................................Ph Eur/NF
Succinic acid..............................................HSE
Colloidal silicon dioxide............................Ph Eur/USP
[...]
Strawberry powder flavour........................HSE
Orange powder flavour..............................HSE
[...]
EXCIPIENTS
Xanthan gum, colloidal silicon dioxide, saccharin sodium, hydroxypropylmethyl cellulose (hypromellose) and silicon dioxide are specified as complying with published Ph Eur monographs. Xanthan gum, colloidal silicon dioxide and hypromellose are additionally specified as complying with corresponding USP/NF monographs. [...] An ‘in house’ specification for succinic acid has been provided, based on the supplier’s own specification. Satisfactory evidence of compliance has been presented. In-house specifications have also been provided for the strawberry, orange and lemon flavouring agents."
http://www.mhra.gov.uk/home/groups/par/documents/websitereso...
--------------------------------------------------
Note added at 11 hrs (2016-05-08 07:03:15 GMT)
--------------------------------------------------
One more for luck:
" 10 mg tablet
Obeticholic acid 10.0 mg* API HSE
Microcrystalline cellulose 176.0 mg* Filler/Binder USP-NF/EP/JP
[...]
API: Active pharmaceutical ingredient
HSE = In house specification
USP-NF = US Pharmacopeia National Formulary
Ph Eur = European Pharmacopeia
JP =Japanese Pharmacopeia"
http://www.google.com/patents/WO2013192097A1?cl=en
Peer comment(s):
agree |
Tony M
: Bravo, short for 'house' of course!
7 mins
|
Thanks, Tony! This one took some finding :)
|
|
agree |
Yasutomo Kanazawa
: A well-done, extensive research on the subject. Hats off!
1 hr
|
Thank you very much, Yasutomo-san! Note the reference to the Japanese Pharmacopeia right at the end :)
|
|
agree |
Yvonne Gallagher
: good one for pharma glossary!
2 hrs
|
Many thanks :)
|
|
agree |
lorenab23
: I knew it wasn't the Health and Safety Executive but couldn't find anything else and gave up. Hats off to you!!!
8 hrs
|
Thanks :) I was pretty sure it couldn't be that, but it took a while to get beyond it!
|
|
agree |
acetran
2 days 9 hrs
|
Thanks, acetran :)
|
|
agree |
Nivetha Velupur
346 days
|
Thanks, Nivetha :)
|
4 KudoZ points awarded for this answer.
Comment: "Selected automatically based on peer agreement."
Reference comments
2 hrs
Reference:
Uk government site
4 hrs
Reference:
?
Health and Safety Executive
The Health and Safety Executive has produced a range of health and safety law products. The Health and safety law poster must be displayed on all business premises. There are various versions of the poster, so that you can select the most appropriate for your business, depending on where in the UK your business is based.
http://www.hse.gov.uk/pubns/books/lawposter.htm
The Health and Safety Executive has produced a range of health and safety law products. The Health and safety law poster must be displayed on all business premises. There are various versions of the poster, so that you can select the most appropriate for your business, depending on where in the UK your business is based.
http://www.hse.gov.uk/pubns/books/lawposter.htm
Peer comments on this reference comment:
disagree |
acetran
: As you said, the reference isn't particularly helpful.
You are always welcome!
2 days 16 hrs
|
Thank you, acetran, though I think that in this case, the reference isn't particularly helpful!// Thank you so much for taking the time to remove your agreement and replace it with a disagreement.
|
Discussion
Not quite sure why ref doesn't want to appear.